Trial Outcomes & Findings for Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR] (NCT NCT00700258)

NCT ID: NCT00700258

Last Updated: 2024-09-23

Results Overview

OS was defined as the time from initiation of treatment to death from any cause. In case a death was documented, but date of death was unknown, the date of death was substituted with the latest available date for the participant (last visit, last contact date, date of assessment). If no death was documented, participant was censored with the latest available contact date or assessment date within study. If these rules led to a missing duration or a negative duration, duration was set to maximum of (PFS,"1 day"). Progression free survival (PFS) was defined as time from initiation of treatment to documented disease progression or death from any cause. progression was defined as the enlargement of the measured sum by 20% or one or more new lesions. This outcome measure was analyzed using Kaplan-Meier method.

• Recruitment status: COMPLETED
• Target enrollment: 1520 participants
• Primary outcome timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months
• Results posted on: 2024-09-23

Participant Flow

Data from eligible participants diagnosed with metastatic renal cell carcinoma (mRCC), relapsed or refractory mantle cell lymphoma (MCL) or gastrointestinal stromal tumors (GIST) and who were treated with temsirolimus, sunitinib and/or axitinib, as per routine clinical practice from January 2008 to December 2021 were observed in this prospective, non-interventional, STAR-TOR registry study.

Participant milestones

Measure	Participants With mRCC, MCL or GIST Participants diagnosed with mRCC, MCL or GIST who received temsirolimus, sunitinib and/or axitinib from January 2008 to December 2021 (approximately 14 years), as per routine clinical practice. Due to the non-interventional nature of the registry, no specific requirements were applied regarding the management of treatment. Dosing and duration of treatment was decided by the physician according to individual treatment requirements of the participant. Summary of product characteristics was considered: the daily dose of temsirolimus for mRCC participants was either 25 milligrams (mg) or 50 mg once per week and for MCL participants was 175 mg for first 3 weeks and later reduced to 75 mg. The daily dose for sunitinib should not exceed 75 mg or drop below 25 mg; the recommended starting dose of axitinib was 5 mg twice daily. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus, sunitinib or axitinib was discontinued or documentation was stopped for any reason.
Overall Study STARTED	1520
Overall Study Participants With mRCC	1435
Overall Study Participants With MCL	59
Overall Study Participants With GIST	26
Overall Study Participants With mRCC Who Received Temsirolimus	605
Overall Study Participants With mRCC Who Received Sunitinib	702
Overall Study Participants With mRCC Who Received Axitinib	237
Overall Study Participants With MCL Who Received Temsirolimus	59
Overall Study Participants With GIST Who Received Sunitinib	26
Overall Study COMPLETED	289
Overall Study NOT COMPLETED	1231

Reasons for withdrawal

Measure	Participants With mRCC, MCL or GIST Participants diagnosed with mRCC, MCL or GIST who received temsirolimus, sunitinib and/or axitinib from January 2008 to December 2021 (approximately 14 years), as per routine clinical practice. Due to the non-interventional nature of the registry, no specific requirements were applied regarding the management of treatment. Dosing and duration of treatment was decided by the physician according to individual treatment requirements of the participant. Summary of product characteristics was considered: the daily dose of temsirolimus for mRCC participants was either 25 milligrams (mg) or 50 mg once per week and for MCL participants was 175 mg for first 3 weeks and later reduced to 75 mg. The daily dose for sunitinib should not exceed 75 mg or drop below 25 mg; the recommended starting dose of axitinib was 5 mg twice daily. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus, sunitinib or axitinib was discontinued or documentation was stopped for any reason.
Overall Study Premature discontinuation of documentation	136
Overall Study Type of study end not documented	1
Overall Study Lost to Follow-up	81
Overall Study Premature discontinuation of therapy	1013

Baseline Characteristics

Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.

Baseline characteristics by cohort

Measure	Participants With mRCC, MCL or GIST n=1520 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.
Age, Customized mRCC - Temsirolimus · Less than (<) 40 years	2 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Temsirolimus · 40 - <50 years	34 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Temsirolimus · 50 - <60 years	106 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Temsirolimus · 60 - <70 years	188 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Temsirolimus · 70 - <80 years	238 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Temsirolimus · 80 - <90 years	36 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Temsirolimus · 90 - <100 years	0 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Temsirolimus · Missing	1 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Sunitinib · Less than (<) 40 years	5 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Sunitinib · 40 - <50 years	29 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Sunitinib · 50 - <60 years	128 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Sunitinib · 60 - <70 years	222 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Sunitinib · 70 - <80 years	252 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Sunitinib · 80 - <90 years	66 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Sunitinib · 90 - <100 years	0 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Sunitinib · Missing	0 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Axitinib · Less than (<) 40 years	3 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Axitinib · 40 - <50 years	5 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Axitinib · 50 - <60 years	47 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Axitinib · 60 - <70 years	67 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Axitinib · 70 - <80 years	92 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Axitinib · 80 - <90 years	23 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Axitinib · 90 - <100 years	0 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized mRCC - Axitinib · Missing	0 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized MCL - Temsirolimus · Less than (<) 40 years	0 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized MCL - Temsirolimus · 40 - <50 years	0 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized MCL - Temsirolimus · 50 - <60 years	3 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized MCL - Temsirolimus · 60 - <70 years	11 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized MCL - Temsirolimus · 70 - <80 years	33 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized MCL - Temsirolimus · 80 - <90 years	11 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized MCL - Temsirolimus · 90 - <100 years	1 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized MCL - Temsirolimus · Missing	0 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized GIST - Sunitinib · Less than (<) 40 years	1 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized GIST - Sunitinib · 40 - <50 years	1 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized GIST - Sunitinib · 50 - <60 years	3 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized GIST - Sunitinib · 60 - <70 years	7 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized GIST - Sunitinib · 70 - <80 years	12 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized GIST - Sunitinib · 80 - <90 years	2 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized GIST - Sunitinib · 90 - <100 years	0 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Age, Customized GIST - Sunitinib · Missing	0 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized mRCC - Temsirolimus · Male	410 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized mRCC - Temsirolimus · Female	191 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized mRCC - Temsirolimus · Missing	4 Participants n=605 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized mRCC - Sunitinib · Male	510 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized mRCC - Sunitinib · Female	187 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized mRCC - Sunitinib · Missing	5 Participants n=702 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized mRCC - Axitinib · Male	163 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized mRCC - Axitinib · Female	71 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized mRCC - Axitinib · Missing	3 Participants n=237 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized MCL - Temsirolimus · Male	41 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized MCL - Temsirolimus · Female	18 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized MCL - Temsirolimus · Missing	0 Participants n=59 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized GIST - Sunitinib · Male	17 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized GIST - Sunitinib · Female	8 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.
Sex/Gender, Customized GIST - Sunitinib · Missing	1 Participants n=26 Participants • Participants mentioned here are not exclusive to one treatment, one participant could have received more than one treatment.

PRIMARY outcome

Timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months

Population: Effectiveness analysis set (EAS): all participants included in study with at least 1 information on: date of death, progression, assessment of response to therapy by physician or assessment to either effectiveness or tolerability of therapy by physician. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.

OS was defined as the time from initiation of treatment to death from any cause. In case a death was documented, but date of death was unknown, the date of death was substituted with the latest available date for the participant (last visit, last contact date, date of assessment). If no death was documented, participant was censored with the latest available contact date or assessment date within study. If these rules led to a missing duration or a negative duration, duration was set to maximum of (PFS,"1 day"). Progression free survival (PFS) was defined as time from initiation of treatment to documented disease progression or death from any cause. progression was defined as the enlargement of the measured sum by 20% or one or more new lesions. This outcome measure was analyzed using Kaplan-Meier method.

Outcome measures

Measure	mRCC - Temsirolimus n=577 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=651 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=221 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=55 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=24 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Overall Survival (OS)	11.04 Months Interval 9.56 to 13.04	25.36 Months Interval 22.18 to 28.22	18.37 Months Interval 14.03 to 24.15	15.11 Months Interval 8.54 to 22.01	16.30 Months Interval 7.29 to 53.22

PRIMARY outcome

Timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months

Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.

PFS was defined as time from initiation of treatment to documented disease progression or death from any cause. The presence of a progression i.e. enlargement of the measured sum by 20% or one or more new lesions was confirmed, but (a) No date was documented: the date of last intake of study medication was used as date of progression, otherwise the date of the last visit with a documented "non-progression" was used as date of progression. (b) Dates within a visit and on final documentation were contradictory, the prior date was used. In case a death was documented within survival follow-up, but no progression was documented within regular study, the date of last visit plus 1 day was used as date of progression. In case no progression was documented, participant was censored with the latest available contact date or assessment date within study. In case these rules led to a missing duration or a negative duration, duration was set to "1 day". Kaplan-Meier method was used for analysis.

Outcome measures

Measure	mRCC - Temsirolimus n=577 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=651 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=221 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=55 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=24 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Progression Free Survival (PFS)	3.91 Months Interval 3.45 to 4.63	6.93 Months Interval 6.24 to 8.25	5.75 Months Interval 4.9 to 6.64	3.68 Months Interval 3.02 to 4.86	10.32 Months Interval 3.58 to 12.94

PRIMARY outcome

Timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months

Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, 'Number Analyzed' signifies those participants who were evaluable for the specified rows.

BOR included Complete Remission (CR): complete disappearance of all lesions. Partial Remission (PR): Reduction of the measured total by at least 30%. Minor remission (MR): ≥10% decrease in the sum of longest diameters of target lesions but not a PR (<30%). Stable Disease (SD): neither shrinkage for CR/PR nor increase for progressive disease (PD) taking as reference smallest sum of longest diameters (SLDs) since treatment start. PD: Enlargement of the measured sum by 20% or one or more new lesions. In this outcome measure, number of participants with best overall response were reported.

Outcome measures

Measure	mRCC - Temsirolimus n=577 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=651 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=221 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=55 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=24 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Number of Participants With Best Overall Response (BOR) CR	5 Participants	40 Participants	3 Participants	1 Participants	0 Participants
Number of Participants With Best Overall Response (BOR) PR	70 Participants	166 Participants	39 Participants	14 Participants	6 Participants
Number of Participants With Best Overall Response (BOR) MR	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Best Overall Response (BOR) SD	237 Participants	221 Participants	75 Participants	10 Participants	11 Participants
Number of Participants With Best Overall Response (BOR) PD	169 Participants	146 Participants	58 Participants	17 Participants	6 Participants
Number of Participants With Best Overall Response (BOR) Response could not be assessed	88 Participants	59 Participants	39 Participants	10 Participants	1 Participants
Number of Participants With Best Overall Response (BOR) Missing	8 Participants	19 Participants	7 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months

Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.

In this outcome measure, number of participants were categorized according to physician's global assessment of effectiveness as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.

Outcome measures

Measure	mRCC - Temsirolimus n=505 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=575 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=195 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=48 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=23 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Number of Participants Categorized According to Physician's Global Assessment of Effectiveness Missing	25 Participants	29 Participants	8 Participants	2 Participants	2 Participants
Number of Participants Categorized According to Physician's Global Assessment of Effectiveness Very good	35 Participants	57 Participants	6 Participants	2 Participants	0 Participants
Number of Participants Categorized According to Physician's Global Assessment of Effectiveness Good	176 Participants	227 Participants	78 Participants	20 Participants	10 Participants
Number of Participants Categorized According to Physician's Global Assessment of Effectiveness Moderate	110 Participants	112 Participants	43 Participants	12 Participants	3 Participants
Number of Participants Categorized According to Physician's Global Assessment of Effectiveness Insufficient	159 Participants	150 Participants	60 Participants	12 Participants	8 Participants

PRIMARY outcome

Timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months

Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure. This outcome measure was not planned to be analyzed for MCL.

Karnofsky performance score was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. Karnofsky performance score ranges between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks.

Outcome measures

Measure	mRCC - Temsirolimus n=478 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=547 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=175 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=18 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Karnofsky Performance Status (KPS) Scale	71.9 Units on a scale Standard Deviation 15.4	78.8 Units on a scale Standard Deviation 14.1	77.9 Units on a scale Standard Deviation 13.2	77.8 Units on a scale Standard Deviation 8.8	—

PRIMARY outcome

Timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months

Population: EAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.

ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, 2) and missing was evaluated for MCL as planned.

Outcome measures

Measure	mRCC - Temsirolimus n=48 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma ECOG: 0	5 Participants	—	—	—	—
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma ECOG: 1	24 Participants	—	—	—	—
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma ECOG: 2	13 Participants	—	—	—	—
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status for Mantle Cell Lymphoma Missing	6 Participants	—	—	—	—

PRIMARY outcome

Timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months

Population: Safety analysis set (SAS) comprised of all prospectively documented participants with histologically proven diagnosis of either mRCC, MCL or GIST and at least 1 documented administration of temsirolimus, sunitinib or axitinib or any non-Pfizer treatment. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.

An adverse event (AE) was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. An SAE was any undesirable medical event that occurred in a participant received a medicinal product or dietary supplement (including infant formula) at any dose, and that resulted in death; was life-threatening; required an unforeseen hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial impairment of the ability to perform daily activities); resulted in a congenital malformation/birth defect. TEAEs were events between first dose of study drug and up to last documented follow-up visit that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and all non-serious adverse events.

Outcome measures

Measure	mRCC - Temsirolimus n=605 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=702 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=237 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=59 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=26 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	460 Participants	585 Participants	187 Participants	53 Participants	20 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	269 Participants	284 Participants	111 Participants	26 Participants	11 Participants

PRIMARY outcome

Timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.

An AE was any undesirable medical event in a participant took a medicinal product. It was not necessarily required that the event is causally related to the treatment or use of the medicinal product. In this outcome measure number of participants who discontinued treatment due to adverse events were reported.

Outcome measures

Measure	mRCC - Temsirolimus n=605 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=702 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=237 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=59 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=26 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Number of Participants Who Discontinued Treatment Due to Adverse Events	108 Participants	142 Participants	60 Participants	17 Participants	5 Participants

PRIMARY outcome

Timeframe: From initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, approximately 13 years and 10 months

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.

In this outcome measure, number of participants were categorized according to physician's global tolerability assessment as very good, good, moderate, insufficient and missing. Categories were determined by investigator's discretion.

Outcome measures

Measure	mRCC - Temsirolimus n=505 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=576 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=195 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=49 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=24 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Number of Participants Categorized According to Physician's Global Tolerability Assessment Very good	93 Participants	49 Participants	21 Participants	5 Participants	3 Participants
Number of Participants Categorized According to Physician's Global Tolerability Assessment Good	306 Participants	370 Participants	123 Participants	25 Participants	16 Participants
Number of Participants Categorized According to Physician's Global Tolerability Assessment Moderate	68 Participants	107 Participants	31 Participants	13 Participants	3 Participants
Number of Participants Categorized According to Physician's Global Tolerability Assessment Insufficient	34 Participants	40 Participants	18 Participants	4 Participants	0 Participants
Number of Participants Categorized According to Physician's Global Tolerability Assessment Missing	4 Participants	10 Participants	2 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Week 46 up to Week 55 post study inclusion

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows.

Outcome measures

Measure	mRCC - Temsirolimus n=42 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=115 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=42 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=2 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=8 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit Neutrophils	67.1 Percentage of blood cells in blood Standard Deviation 13.2	56.0 Percentage of blood cells in blood Standard Deviation 14.0	64.4 Percentage of blood cells in blood Standard Deviation 10.8	58.7 Percentage of blood cells in blood Standard Deviation 1.0	58.7 Percentage of blood cells in blood Standard Deviation 13.7
Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit Lymphocytes	18.8 Percentage of blood cells in blood Standard Deviation 8.5	31.1 Percentage of blood cells in blood Standard Deviation 12.0	23.7 Percentage of blood cells in blood Standard Deviation 9.1	22.5 Percentage of blood cells in blood Standard Deviation 8.6	28.9 Percentage of blood cells in blood Standard Deviation 12.6
Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit Monocytes	8.9 Percentage of blood cells in blood Standard Deviation 3.7	8.7 Percentage of blood cells in blood Standard Deviation 3.3	8.4 Percentage of blood cells in blood Standard Deviation 2.3	14.2 Percentage of blood cells in blood Standard Deviation 6.9	8.8 Percentage of blood cells in blood Standard Deviation 2.9
Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit Eosinophils	2.6 Percentage of blood cells in blood Standard Deviation 1.9	2.9 Percentage of blood cells in blood Standard Deviation 2.3	3.0 Percentage of blood cells in blood Standard Deviation 1.4	4.3 Percentage of blood cells in blood Standard Deviation 2.8	2.1 Percentage of blood cells in blood Standard Deviation 2.5
Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit Basophils	0.4 Percentage of blood cells in blood Standard Deviation 0.4	0.4 Percentage of blood cells in blood Standard Deviation 0.3	0.5 Percentage of blood cells in blood Standard Deviation 0.4	0.4 Percentage of blood cells in blood Standard Deviation 0.1	0.2 Percentage of blood cells in blood Standard Deviation 0.1
Absolute Laboratory Values of Hematology Parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Hematocrit Hematocrit	33.8 Percentage of blood cells in blood Standard Deviation 3.5	37.0 Percentage of blood cells in blood Standard Deviation 5.2	42.7 Percentage of blood cells in blood Standard Deviation 5.2	—	—

PRIMARY outcome

Timeframe: Week 46 up to Week 55 post study inclusion

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for HbA1c in MCL arm.

Outcome measures

Measure	mRCC - Temsirolimus n=3 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=22 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=4 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=2 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Absolute Laboratory Values of Hematology Parameters: Hemoglobin A1c (HbA1c)	7.9 Percentage of HbA1c Standard Deviation 1.2	5.8 Percentage of HbA1c Standard Deviation 0.8	5.9 Percentage of HbA1c Standard Deviation 0.9	—	7.5 Percentage of HbA1c Standard Deviation 3.2

PRIMARY outcome

Timeframe: Week 46 up to Week 55 post study inclusion

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.

Outcome measures

Measure	mRCC - Temsirolimus n=72 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=163 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=45 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=3 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=9 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Absolute Laboratory Values of Hematology Parameters: Hemoglobin	11.2 Grams per deciliter Standard Deviation 1.6	12.2 Grams per deciliter Standard Deviation 2.0	14.4 Grams per deciliter Standard Deviation 1.7	12.6 Grams per deciliter Standard Deviation 0.8	11.9 Grams per deciliter Standard Deviation 1.2

PRIMARY outcome

Timeframe: Week 46 up to Week 55 post study inclusion

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows.

Outcome measures

Measure	mRCC - Temsirolimus n=63 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=153 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=41 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=2 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=8 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose Sodium	136.0 Millimoles per liter Standard Deviation 19.1	139.1 Millimoles per liter Standard Deviation 3.6	138.1 Millimoles per liter Standard Deviation 4.0	138.0 Millimoles per liter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.	139.0 Millimoles per liter Standard Deviation 2.7
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose Potassium	4.3 Millimoles per liter Standard Deviation 0.6	4.5 Millimoles per liter Standard Deviation 0.6	4.4 Millimoles per liter Standard Deviation 0.6	3.6 Millimoles per liter Standard Deviation 0.0	4.1 Millimoles per liter Standard Deviation 0.9
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose Magnesium	1.2 Millimoles per liter Standard Deviation 0.7	0.8 Millimoles per liter Standard Deviation 0.3	0.7 Millimoles per liter Standard Deviation 0.1	—	0.9 Millimoles per liter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose Calcium	2.3 Millimoles per liter Standard Deviation 0.4	2.3 Millimoles per liter Standard Deviation 0.3	2.6 Millimoles per liter Standard Deviation 1.1	2.4 Millimoles per liter Standard Deviation 0.1	2.3 Millimoles per liter Standard Deviation 0.1
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose Phosphate	1.4 Millimoles per liter Standard Deviation 0.9	1.1 Millimoles per liter Standard Deviation 0.5	1.4 Millimoles per liter Standard Deviation 0.9	—	0.9 Millimoles per liter Standard Deviation 0.2
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose Cholesterol	6.0 Millimoles per liter Standard Deviation 1.9	5.1 Millimoles per liter Standard Deviation 1.3	6.6 Millimoles per liter Standard Deviation 1.3	—	5.9 Millimoles per liter Standard Deviation 2.1
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose Triglycerides	3.2 Millimoles per liter Standard Deviation 3.4	2.4 Millimoles per liter Standard Deviation 1.1	3.5 Millimoles per liter Standard Deviation 2.5	—	5.2 Millimoles per liter Standard Deviation 3.4
Absolute Laboratory Values of Clinical Chemistry Parameters: Calcium, Sodium, Potassium, Phosphate, Magnesium, Cholesterol, Triglycerides and Glucose Glucose	54.7 Millimoles per liter Standard Deviation 62.6	39.4 Millimoles per liter Standard Deviation 52.4	71.4 Millimoles per liter Standard Deviation 78.4	—	77.2 Millimoles per liter Standard Deviation 143.2

PRIMARY outcome

Timeframe: Week 46 up to Week 55 post study inclusion

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows.

Outcome measures

Measure	mRCC - Temsirolimus n=54 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=152 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=42 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=2 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=9 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin Creatinine	1.4 Milligrams per deciliter Standard Deviation 0.5	1.4 Milligrams per deciliter Standard Deviation 0.8	1.3 Milligrams per deciliter Standard Deviation 0.5	0.7 Milligrams per deciliter Standard Deviation 0.0	1.1 Milligrams per deciliter Standard Deviation 0.3
Absolute Laboratory Values of Clinical Chemistry Parameters: Creatinine, Total Bilirubin Total bilirubin	0.9 Milligrams per deciliter Standard Deviation 1.7	0.7 Milligrams per deciliter Standard Deviation 1.1	0.5 Milligrams per deciliter Standard Deviation 0.3	0.3 Milligrams per deciliter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.	0.4 Milligrams per deciliter Standard Deviation 0.1

PRIMARY outcome

Timeframe: Week 46 up to Week 55 post study inclusion

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows.

Outcome measures

Measure	mRCC - Temsirolimus n=52 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=145 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=39 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=1 Participants Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=9 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) AST	23.1 Units per liter Standard Deviation 8.2	29.6 Units per liter Standard Deviation 12.8	44.3 Units per liter Standard Deviation 84.3	28.0 Units per liter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.	24.6 Units per liter Standard Deviation 6.4
Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) ALP	95.8 Units per liter Standard Deviation 53.5	77.9 Units per liter Standard Deviation 30.6	91.8 Units per liter Standard Deviation 43.2	130.0 Units per liter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.	79.3 Units per liter Standard Deviation 50.7
Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) ALT	20.2 Units per liter Standard Deviation 8.3	25.9 Units per liter Standard Deviation 17.5	34.7 Units per liter Standard Deviation 71.8	24.0 Units per liter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.	22.9 Units per liter Standard Deviation 7.5
Absolute Laboratory Values of Clinical Chemistry Parameters: Alanine Transaminase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) LDH	224.8 Units per liter Standard Deviation 88.2	245.1 Units per liter Standard Deviation 67.2	235.8 Units per liter Standard Deviation 126.9	256.0 Units per liter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.	227.8 Units per liter Standard Deviation 45.6

PRIMARY outcome

Timeframe: Week 46 up to Week 55 post study inclusion

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for albumin in MCL arm.

Outcome measures

Measure	mRCC - Temsirolimus n=10 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=76 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=16 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=1 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Absolute Laboratory Values of Clinical Chemistry Parameters: Albumin	31.1 Grams per liter Standard Deviation 17.1	33.6 Grams per liter Standard Deviation 14.4	31.6 Grams per liter Standard Deviation 14.8	—	42.0 Grams per liter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.

PRIMARY outcome

Timeframe: Week 46 up to Week 55 post study inclusion

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for fT3 and fT4 in MCL and GIST arms.

Outcome measures

Measure	mRCC - Temsirolimus n=1 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=46 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=20 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) fT3	3.5 Picomoles per liter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.	3.7 Picomoles per liter Standard Deviation 1.0	3.8 Picomoles per liter Standard Deviation 1.3	—	—
Absolute Laboratory Values of Clinical Chemistry Parameters: Triiodothyronine (fT3) and Free Thyroxine (fT4) fT4	15.4 Picomoles per liter Standard Deviation NA Standard deviation was not calculated as only 1 participant was evaluable.	14.8 Picomoles per liter Standard Deviation 4.8	13.7 Picomoles per liter Standard Deviation 6.1	—	—

PRIMARY outcome

Timeframe: Week 46 up to Week 55 post study inclusion

Population: SAS analyzed. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here N=0 signifies that participants were not evaluable at the specified time point for TSH in MCL arm.

Outcome measures

Measure	mRCC - Temsirolimus n=28 Participants Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=97 Participants Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=27 Participants Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=6 Participants Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
Absolute Laboratory Values of Clinical Chemistry Parameters: Thyroid Stimulating Hormone (TSH)	1.5 Milliunits per liter Standard Deviation 1.4	3.5 Milliunits per liter Standard Deviation 3.4	3.4 Milliunits per liter Standard Deviation 2.4	—	1.6 Milliunits per liter Standard Deviation 1.1

Adverse Events

mRCC - Temsirolimus

Serious events: 269 serious events

Other events: 342 other events

Deaths: 440 deaths

mRCC - Sunitinib

Serious events: 284 serious events

Other events: 485 other events

Deaths: 420 deaths

mRCC - Axitinib

Serious events: 111 serious events

Other events: 148 other events

Deaths: 163 deaths

MCL - Temsirolimus

Serious events: 26 serious events

Other events: 45 other events

Deaths: 40 deaths

GIST - Sunitinib

Serious events: 11 serious events

Other events: 18 other events

Deaths: 16 deaths

Serious adverse events

Measure	mRCC - Temsirolimus n=605 participants at risk Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=702 participants at risk Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=237 participants at risk Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=59 participants at risk Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=26 participants at risk Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
General disorders Fatigue	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Disease progression	10.9% 66/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.0% 35/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.0% 19/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	6.8% 4/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	11.5% 3/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders General physical health deterioration	6.4% 39/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.6% 39/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	6.8% 16/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	10.2% 6/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Oedema peripheral	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Mucosal inflammation	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Pain	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Pyrexia	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Asthenia	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Condition aggravated	1.3% 8/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Chest pain	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Chills	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Multiple organ dysfunction syndrome	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Impaired healing	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Malaise	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Peripheral swelling	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Death	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.0% 7/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Systemic inflammatory response syndrome	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Concomitant disease progression	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Inflammation	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Oedema	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Gait disturbance	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Organ failure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Chest discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Sudden death	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Nausea	1.7% 10/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.1% 8/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Diarrhoea	1.3% 8/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.6% 11/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.5% 13/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Vomiting	1.8% 11/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.4% 10/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.5% 6/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Stomatitis	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Ascites	1.2% 7/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Constipation	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal pain upper	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal pain	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Aphthous ulcer	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal distension	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Dysphagia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Inguinal hernia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Melaena	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gastritis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Subileus	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Swollen tongue	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Anal haemorrhage	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Colitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Diverticulum intestinal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Functional gastrointestinal disorder	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Hiatus hernia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Large intestinal stenosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Large intestine polyp	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Mallory-Weiss syndrome	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oesophagitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Pancreatic disorder	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Proctalgia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Diverticular perforation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Proctitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gastric ulcer	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Pancreatitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Anal skin tags	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Anal stenosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Haematemesis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Intestinal perforation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oedema mouth	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Pancreatic duct obstruction	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Dry mouth	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Ileus	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Rectal ulcer haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.8% 17/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.1% 15/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.6% 11/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.5% 21/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.1% 3/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Acquired diaphragmatic eventration	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Apnoea	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Bronchial disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Vocal cord disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Anaemia	2.5% 15/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.1% 15/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Thrombocytopenia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.6% 11/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Neutropenia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Leukocytosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Nephrogenic anaemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Immune thrombocytopenia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Leukopenia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pneumonia	4.0% 24/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.7% 19/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.2% 10/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.1% 3/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Bronchitis	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Urinary tract infection	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.5% 5/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Infection	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Erysipelas	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Sepsis	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Gastroenteritis	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Candida infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Herpes zoster	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Atypical pneumonia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Clostridium difficile colitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Diverticulitis	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Escherichia infection	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pneumocystis jirovecii infection	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pyelonephritis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Bronchopulmonary aspergillosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Device related infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Endometritis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Enterococcal infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Gangrene	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Intervertebral discitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Ophthalmic herpes zoster	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Peritonitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Peritonitis bacterial	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pneumocystis jirovecii pneumonia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pneumonia staphylococcal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Purulence	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Septic shock	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Wound infection staphylococcal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Staphylococcal infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Anal abscess	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Clostridial infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Cystitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Gastroenteritis norovirus	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Upper respiratory tract infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Wound infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Appendicitis perforated	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Breast abscess	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Bursitis infective	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Candida pneumonia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Haemophilus infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Necrotising fasciitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Oesophageal candidiasis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Osteomyelitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Urosepsis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Vulval abscess	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pulmonary sepsis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Nasopharyngitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Bacterial infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Paronychia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Vascular device infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Pruritus	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Night sweats	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood creatinine increased	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Haemoglobin decreased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Weight decreased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood glucose abnormal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Ejection fraction decreased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Hepatic enzyme abnormal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Lipids abnormal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood lactate dehydrogenase increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Liver function test increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood urine present	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations C-reactive protein increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Urine output decreased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood pressure increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood electrolytes abnormal	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Decreased appetite	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hyperglycaemia	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Cachexia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Dehydration	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.1% 8/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.5% 6/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hyperkalaemia	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hyponatraemia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypokalaemia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Diabetes mellitus	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypophagia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Metabolic acidosis	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypophosphataemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Alkalosis hypochloraemic	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Dizziness	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Paraesthesia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Somnolence	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Aphasia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Brain oedema	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Cerebral haemorrhage	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Cerebrovascular accident	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Generalised tonic-clonic seizure	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Head titubation	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Hemiparesis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Loss of consciousness	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Monoplegia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Movement disorder	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Paralysis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Paraplegia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Partial seizures	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Syncope	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Transient ischaemic attack	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Ageusia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Hypoaesthesia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Epilepsy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Cerebral infarction	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Paresis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Seizure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Intracranial mass	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Monoparesis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Orthostatic intolerance	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Paraparesis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Headache	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Altered state of consciousness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Ischaemic stroke	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Leukoencephalopathy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Lethargy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Basal ganglia infarction	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	4.3% 26/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.1% 15/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.0% 7/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	1.3% 8/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 27/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	11.5% 3/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	1.7% 10/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.3% 16/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.5% 6/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebral haemangioma	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.1% 3/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	7.7% 2/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Arthralgia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Back pain	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Spinal pain	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Pathological fracture	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Neck pain	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Osteolysis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Bone lesion	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Synovial cyst	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiac failure	2.0% 12/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Atrial fibrillation	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Tachycardia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Acute myocardial infarction	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Bradycardia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiac arrest	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiac failure acute	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Coronary artery disease	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Myocardial infarction	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Arrhythmia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Atrioventricular block complete	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiogenic shock	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiopulmonary failure	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cor pulmonale acute	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Supraventricular tachycardia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Ventricular fibrillation	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiovascular disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Pericardial effusion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Arteriospasm coronary	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Atrioventricular block first degree	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Bifascicular block	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Gastrocardiac syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Left ventricular failure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Right ventricular failure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Sinoatrial block	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Angina pectoris	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Acute coronary syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Intracardiac thrombus	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Renal failure	1.3% 8/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Acute kidney injury	1.2% 7/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.1% 8/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Haematuria	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Dysuria	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Renal impairment	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Urinary retention	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Azotaemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Bladder tamponade	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Chronic kidney disease	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Renal hypertension	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Vesical fistula	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Postrenal failure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Prerenal failure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Proteinuria	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Renal disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Urethral caruncle	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Urethral stenosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders End stage renal disease	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Hydronephrosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Renal pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Hypertension	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Haematoma	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Hypertensive crisis	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Hypotension	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Circulatory collapse	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Deep vein thrombosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Shock	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Venous thrombosis limb	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Aortic aneurysm	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Lymphoedema	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Aneurysm ruptured	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Aortic dissection rupture	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Embolism	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Leriche syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Peripheral artery thrombosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Shock haemorrhagic	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Aortic aneurysm rupture	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Arterial disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Extremity necrosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Superior vena cava occlusion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Thrombosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Venous occlusion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Fall	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Skin laceration	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Incisional hernia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Femoral neck fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Femur fracture	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Clavicle fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Concussion	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Contusion	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Facial bones fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Head injury	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Humerus fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Infusion related reaction	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Lower limb fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Seroma	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Spinal column injury	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Spinal fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Upper limb fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Wound	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Foreign body	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Pneumonitis chemical	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Radiation associated pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Vascular bypass dysfunction	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Overdose	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Depression	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Panic attack	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Confusional state	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Suicidal ideation	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Disorientation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Delirium	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Completed suicide	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Restlessness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Suicide attempt	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Papilloedema	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Diplopia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Retinal vein occlusion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Cholecystitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Cholecystitis acute	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Hepatic cirrhosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Hepatic failure	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Hepatomegaly	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Jaundice	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Cholestasis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Cholelithiasis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Biliary obstruction	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Cholangitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Cholangitis acute	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Arthrectomy	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Central venous catheterisation	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Nephrectomy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Surgery	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Leg amputation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Adrenocortical insufficiency acute	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Hypothyroidism	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Hypercalcaemia of malignancy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Hyperthyroidism	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Hyperparathyroidism secondary	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Oedema genital	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Immune system disorders Anaphylactic reaction	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Immune system disorders Anaphylactic shock	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Ear and labyrinth disorders Vertigo	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Product Issues Device dislocation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.

Other adverse events

Measure	mRCC - Temsirolimus n=605 participants at risk Participants diagnosed with mRCC who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	mRCC - Sunitinib n=702 participants at risk Participants diagnosed with mRCC who received sunitinib (some of the participants stopped sunitinib and received axitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.	mRCC - Axitinib n=237 participants at risk Participants diagnosed with mRCC who received axitinib (some of the participants initially received sunitinib) from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with axitinib was discontinued or documentation was stopped for any reason.	MCL - Temsirolimus n=59 participants at risk Participants diagnosed with MCL who received only temsirolimus from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with temsirolimus was discontinued or documentation was stopped for any reason.	GIST - Sunitinib n=26 participants at risk Participants diagnosed with GIST who received only sunitinib from January 2008 to December 2021, as per routine clinical practice were observed during this prospective registry study. Participants in this observational study, were followed up for every 8 to 12 weeks until treatment with sunitinib was discontinued or documentation was stopped for any reason.
General disorders Fatigue	12.9% 78/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	20.5% 144/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	16.5% 39/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	10.2% 6/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	11.5% 3/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Disease progression	1.3% 8/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.0% 14/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 8/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders General physical health deterioration	2.6% 16/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.3% 23/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.1% 5/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.5% 5/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Oedema peripheral	5.8% 35/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 27/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	6.8% 4/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Mucosal inflammation	4.5% 27/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	7.8% 55/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 8/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	6.8% 4/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	11.5% 3/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Pain	4.0% 24/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.9% 13/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.2% 10/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Pyrexia	3.0% 18/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 12/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Asthenia	1.5% 9/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.6% 11/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.5% 6/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.5% 5/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Condition aggravated	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Oedema	1.5% 9/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.9% 13/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Chest pain	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Chills	1.2% 7/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.1% 8/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.1% 3/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Feeling cold	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Impaired healing	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Malaise	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Peripheral swelling	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Swelling	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Swelling face	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Chest discomfort	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Exercise tolerance decreased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Face oedema	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Generalised oedema	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Chronic fatigue syndrome	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Drug intolerance	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Feeling hot	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Gait disturbance	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Localised oedema	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Mucosal dryness	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Non-cardiac chest pain	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Mucosal disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Inflammation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Mucosal haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Complication associated with device	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Drug ineffective	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Facial pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Influenza like illness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Medical device site erosion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Ulcer	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders No adverse event	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Gait inability	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
General disorders Mucosal pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Nausea	7.8% 47/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	12.7% 89/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.0% 19/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	6.8% 4/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Diarrhoea	4.8% 29/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	21.2% 149/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	27.0% 64/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	20.3% 12/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	23.1% 6/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Vomiting	3.6% 22/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.3% 37/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.2% 10/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.5% 5/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	7.7% 2/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Stomatitis	4.3% 26/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	9.7% 68/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 9/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.1% 3/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	11.5% 3/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Ascites	1.7% 10/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Constipation	2.3% 14/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.7% 19/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 8/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal pain upper	1.7% 10/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 9/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal pain	1.8% 11/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.0% 14/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.5% 6/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Aphthous ulcer	1.2% 7/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal distension	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal pain lower	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal discomfort	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Dysphagia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Inguinal hernia	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Melaena	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Dental discomfort	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Dyspepsia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.8% 41/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gastritis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gastrointestinal pain	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oral dysaesthesia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Retching	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Subileus	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Swollen tongue	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal hernia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal wall haematoma	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Anal fistula	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Dental caries	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Dry mouth	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.4% 10/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Flatulence	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	7.7% 2/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Hypoaesthesia oral	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Intra-abdominal fluid collection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Mouth swelling	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Mouth ulceration	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oedema mouth	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oesophageal pain	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oral disorder	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Pancreatic cyst	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Proctitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Tongue exfoliation	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Toothache	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Tongue discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Anal inflammation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Glossodynia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gastric ulcer	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Haematochezia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oral discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oral pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Angular cheilitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Anorectal discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Change of bowel habit	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Chronic gastritis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Eructation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Faeces discoloured	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gingival bleeding	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gingival disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Gingival erythema	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Glossitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Lip swelling	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oral mucosa erosion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Parotid gland enlargement	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Rectal discharge	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Tongue blistering	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Tongue erythema	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Tooth disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Tooth loss	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Colitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Anal incontinence	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Umbilical hernia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Enteritis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Oral mucosal erythema	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Gastrointestinal disorders Haematemesis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.1% 37/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.7% 40/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.6% 11/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.8% 11/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 30/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.1% 29/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.2% 10/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.1% 3/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	2.0% 12/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.5% 9/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.7% 26/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	6.8% 4/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Aphonia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pharyngeal hypoaesthesia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.0% 19/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Rhinitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Anaemia	13.7% 83/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.7% 61/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 9/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	22.0% 13/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Thrombocytopenia	6.0% 36/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	10.4% 73/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	40.7% 24/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	19.2% 5/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Leukopenia	3.3% 20/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	9.7% 68/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	20.3% 12/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	7.7% 2/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Neutropenia	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.1% 8/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Anaemia of malignant disease	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Leukocytosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Nephrogenic anaemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Erythropenia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Iron deficiency anaemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Lymphadenopathy	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Lymphopenia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Haematotoxicity	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pneumonia	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Bronchitis	2.3% 14/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Urinary tract infection	2.1% 13/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.1% 8/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.5% 6/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.1% 3/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Infection	1.7% 10/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.1% 3/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Nasopharyngitis	2.1% 13/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.1% 15/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.1% 3/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Erysipelas	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Oral candidiasis	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Gastrointestinal infection	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Paronychia	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Gastroenteritis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Candida infection	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Gingivitis	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Herpes zoster	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Influenza	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Oral herpes	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Clostridium difficile colitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Cystitis	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Febrile infection	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pustule	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pyelonephritis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Respiratory tract infection	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Tooth abscess	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Upper respiratory tract infection	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Abscess jaw	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Acne pustular	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Breast abscess	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Conjunctivitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Ear infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Enterocolitis bacterial	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Folliculitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Fungal foot infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Herpes dermatitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Herpes simplex	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Hordeolum	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Localised infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Mastitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Parotitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Periodontitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pharyngitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Subcutaneous abscess	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Tooth infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Urinary tract infection bacterial	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Vascular device infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Viral infection	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Sepsis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Clostridial infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Gastroenteritis norovirus	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Onychomycosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Abscess limb	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Escherichia sepsis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Genital infection fungal	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin mass	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Herpes virus infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Infected skin ulcer	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Infection susceptibility increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Pulpitis dental	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Superinfection bacterial	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Tinea pedis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Abdominal wall abscess	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Anal fungal infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Bronchitis bacterial	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Otitis externa	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Otitis media	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Tonsillitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Laryngitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Infections and infestations Skin bacterial infection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Rash	7.3% 44/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.0% 21/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.5% 13/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Pruritus	6.1% 37/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.7% 19/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.5% 6/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Erythema	2.0% 12/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 9/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Onychoclasis	1.7% 10/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	1.7% 10/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	12.1% 85/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	7.2% 17/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	23.1% 6/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Dry skin	1.3% 8/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.9% 13/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Eczema	1.3% 8/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Nail disorder	1.3% 8/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Acne	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Alopecia	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 9/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Night sweats	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin disorder	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin ulcer	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Dermatitis	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin exfoliation	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Rash pruritic	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin lesion	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Epidermolysis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Hair colour changes	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Onycholysis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Pain of skin	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Pemphigoid	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Psoriasis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Rash papular	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin burning sensation	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin toxicity	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Yellow skin	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.9% 13/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Blister	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Scar pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Granuloma annulare	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Lentigo	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Papule	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin depigmentation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin wrinkling	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Skin and subcutaneous tissue disorders Skin discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood creatinine increased	4.3% 26/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.0% 28/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.0% 7/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Haemoglobin decreased	4.8% 29/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 9/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Weight decreased	1.8% 11/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.7% 33/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.9% 21/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood glucose increased	1.8% 11/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood lactate dehydrogenase increased	1.7% 10/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.6% 11/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.1% 5/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood cholesterol increased	1.2% 7/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood triglycerides increased	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations C-reactive protein increased	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Platelet count decreased	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood alkaline phosphatase increased	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood calcium decreased	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood thyroid stimulating hormone increased	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.7% 26/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.1% 5/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Body temperature increased	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood phosphorus increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Gamma-glutamyltransferase increased	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Platelet count increased	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations White blood cell count increased	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Alanine aminotransferase increased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood albumin decreased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood pressure increased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.7% 19/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.5% 6/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood sodium decreased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood triglycerides abnormal	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Haemoglobin	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Lipids increased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Liver function test increased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Lymphocyte count decreased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Weight increased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Amylase abnormal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Aspartate aminotransferase increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood bilirubin increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood calcium increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood cholesterol abnormal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood creatine increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood creatinine decreased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood creatinine	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood immunoglobulin M decreased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood phosphorus decreased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood potassium decreased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood thyroid stimulating hormone decreased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood urea increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Chest X-ray abnormal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Computerised tomogram thorax abnormal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations General physical condition abnormal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Glycosylated haemoglobin increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Haemoglobin increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Heart rate increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Hepatic enzyme increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Neutrophil count increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Quality of life decreased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Red blood cell count decreased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Red blood cell sedimentation rate increased	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations White blood cell count	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood potassium increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood uric acid increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Haematocrit decreased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Transaminases increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations White blood cell count decreased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood glucose	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood glucose abnormal	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood uric acid abnormal	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Creatinine renal clearance decreased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Intraocular pressure increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Lipase increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Lymph node palpable	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Neutrophil count decreased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Prostatic specific antigen increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Somnolence	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood glucose decreased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Blood pressure decreased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Thyroxine free increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Investigations Fibrin D dimer increased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Decreased appetite	4.3% 26/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	9.7% 68/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.9% 21/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	8.5% 5/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	7.7% 2/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hyperglycaemia	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Cachexia	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Dehydration	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hyperkalaemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hyperlipidaemia	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hyponatraemia	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypokalaemia	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Diabetes mellitus	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypercalcaemia	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypophagia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Calcium deficiency	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypoglycaemia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Glucose tolerance impaired	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Gout	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hyperalbuminaemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypercholesterolaemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hyperproteinaemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypocalcaemia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Iron deficiency	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Malnutrition	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Fluid retention	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Dizziness	2.8% 17/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.7% 26/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 8/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Taste disorder	2.3% 14/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	10.5% 74/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	11.5% 3/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Headache	2.0% 12/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	2.7% 19/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.0% 7/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Paraesthesia	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Dysgeusia	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 12/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Hyperaesthesia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Neuropathy peripheral	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Polyneuropathy	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Sciatica	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Neck pain	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Ageusia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.7% 26/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Ataxia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Balance disorder	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Memory impairment	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Restless legs syndrome	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Tremor	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Syncope	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Hypoaesthesia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Epilepsy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Disturbance in attention	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Paresis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Transient ischaemic attack	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Aphasia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Cerebrospinal fluid retention	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Clumsiness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Dementia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Dysaesthesia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Head discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Hypogeusia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Hyposmia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Multiple sclerosis relapse	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Neuralgia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Amnesia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Neurological symptom	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Orthostatic intolerance	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Cerebrovascular insufficiency	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Nervous system disorders Peroneal nerve palsy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 12/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Focal nodular hyperplasia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to skin	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 15/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.1% 22/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.5% 13/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Back pain	2.1% 13/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.0% 21/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 8/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 15/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.0% 28/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 8/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Spinal pain	1.5% 9/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Bone pain	0.99% 6/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 9/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 3/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Flank pain	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.1% 8/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Pathological fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Joint swelling	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Myalgia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Osteolysis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Arthritis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Bursitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Groin pain	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.4% 2/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Muscle disorder	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Osteitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Urge incontinence	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.1% 8/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Pain in jaw	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Scoliosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Spinal disorder	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Weight bearing difficulty	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Fistula	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Musculoskeletal and connective tissue disorders Bone loss	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiac failure	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Atrial fibrillation	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Tachycardia	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Palpitations	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Pericardial effusion	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Angina pectoris	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiac flutter	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiac ventricular thrombosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiomegaly	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiotoxicity	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiovascular insufficiency	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Rhythm idioventricular	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Ventricular extrasystoles	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiovascular disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Arrhythmia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiac arrest	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Cardiac discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Hypertensive heart disease	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Mitral valve incompetence	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Sinus tachycardia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Bundle branch block right	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Left ventricular failure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Cardiac disorders Coronary artery disease	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Renal failure	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Acute kidney injury	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Haematuria	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Dysuria	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Urinary retention	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Bladder pain	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Nephrolithiasis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Nocturia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Proteinuria	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Renal colic	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Urinary incontinence	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Chromaturia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders End stage renal disease	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Hydronephrosis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Microalbuminuria	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Renal pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Ureterolithiasis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Incontinence	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Micturition urgency	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Renal infarct	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Renal and urinary disorders Pollakiuria	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Hypertension	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	9.0% 63/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	5.9% 14/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Lymphoedema	0.83% 5/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Haematoma	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Hypertensive crisis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Hypotension	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Thrombosis	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Hot flush	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Aortic arteriosclerosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Fibromuscular dysplasia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Intermittent claudication	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Jugular vein distension	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Subclavian vein thrombosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Venous thrombosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Aortic aneurysm	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Circulatory collapse	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Blood pressure fluctuation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Flushing	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Peripheral coldness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Peripheral venous disease	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Poor peripheral circulation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Subclavian artery occlusion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Vascular disorders Thrombophlebitis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Fall	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Skin laceration	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Incisional hernia	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Femoral neck fracture	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Nail injury	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Post procedural haematoma	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Radiation oesophagitis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Radiation skin injury	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Skin abrasion	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Thermal burn	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Tongue injury	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Wound	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Anal injury	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Post procedural inflammation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Radiation mucositis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Seroma	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Skin pressure mark	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Stoma site inflammation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Contusion	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Gastrointestinal procedural complication	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Off label use	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Injury, poisoning and procedural complications Vascular procedure complication	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Depression	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.85% 6/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 4/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Panic attack	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Sleep disorder	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 12/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.84% 2/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Anxiety	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Depressed mood	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Insomnia	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Nervousness	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Personality change	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Tobacco abuse	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Transient psychosis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Mood swings	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Claustrophobia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Irritability	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Mental disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Middle insomnia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Restlessness	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Sleep attacks	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Delirium	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Hallucination	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Psychiatric disorders Acute stress disorder	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Eyelid oedema	0.66% 4/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.3% 9/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Visual impairment	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Eye irritation	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Lacrimation increased	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Visual acuity reduced	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Cataract	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Glaucoma	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Iritis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Conjunctival haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Eye swelling	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Periorbital oedema	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.28% 2/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Conjunctival irritation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Exophthalmos	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Eye haemorrhage	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Eye paraesthesia	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Swelling of eyelid	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Eye inflammation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Eye disorders Dry eye	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Bile duct stone	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Cholestasis	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Jaundice	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.71% 5/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Hepatic failure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Hepatobiliary disorders Cholelithiasis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Skin lesion removal	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Red blood cell transfusion	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Stent removal	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Tooth extraction	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Ankle operation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Genital tract inflammation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Cataract operation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Endodontic procedure	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Hyperthermia therapy	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Surgical and medical procedures Jaw operation	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Hyperthyroidism	0.50% 3/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.00% 7/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Hypothyroidism	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	4.3% 30/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	6.8% 16/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Thyroid disorder	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Thyroiditis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Endocrine disorders Goitre	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Balanoposthitis	0.33% 2/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Heavy menstrual bleeding	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Penile oedema	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Vulvovaginal dryness	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Breast pain	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Genital discomfort	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Genital rash	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Reproductive system and breast disorders Oedema genital	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	1.7% 1/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Immune system disorders Anaphylactic reaction	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Immune system disorders Contrast media reaction	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Immune system disorders Hypersensitivity	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Immune system disorders Drug hypersensitivity	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Immune system disorders Corneal graft rejection	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Ear and labyrinth disorders Ear pain	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Ear and labyrinth disorders Vertigo positional	0.17% 1/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Ear and labyrinth disorders Tinnitus	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.57% 4/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Ear and labyrinth disorders Vertigo	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.43% 3/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Ear and labyrinth disorders Hypoacusis	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	3.8% 1/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Product Issues Product supply issue	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Social circumstances Bedridden	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.14% 1/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/605 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/702 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.42% 1/237 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/59 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.	0.00% 0/26 • Day 1 of study treatment up to last documented follow-up visit, up to 13 years 10 months An AE term may be reported as both a serious and non-serious AE, but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or participant may experienced both a serious and non-serious episode of same event. Participants received another treatment if not benefited from treatment they were receiving at enrollment; participants were not exclusive in few arms. So, sum of participants across arms is not equal to number of participants who started study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER