Trial Outcomes & Findings for Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409 (NCT NCT02255656)

NCT ID: NCT02255656

Last Updated: 2022-03-28

Results Overview

An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 \[i.e. up to a maximum of 5.6 years\]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1062 participants
• Primary outcome timeframe: From Baseline until the end of the study (up to a maximum duration of 5.6 years)
• Results posted on: 2022-03-28

Participant Flow

The study was conducted at 142 study centers in 21 countries. A total of 1062 participants were screened between 7 January 2015 and 28 June 2016 and were enrolled in this current study (LPS13649 [TOPAZ]).

Subgroup analysis ([Delayed Alemtuzumab Treatment[DAT] & Immediate Alemtuzumab Treatment[IAT]subgroup) was performed only for outcome measures and safety analysis. Participants who rolled over from CAMMS223(NCT00050778) to CAMMS03409 (NCT00930553),then subsequently enrolled and took 24 mg alemtuzumab in CAMMS324 (NCT00548405) study, were not considered as part of DAT or IAT subgroup & included in overall group only. Participant flow and Baseline analysis was performed on overall population only.

Participant milestones

Measure	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Study STARTED	1062
Overall Study COMPLETED	592
Overall Study NOT COMPLETED	470

Reasons for withdrawal

Measure	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Overall Study Adverse Event	11
Overall Study Poor compliance to protocol	3
Overall Study Lost to Follow-up	30
Overall Study Due to Coronavirus Disease (Covid-19)	300
Overall Study Other	126

Baseline Characteristics

Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409

Baseline characteristics by cohort

Measure	Alemtuzumab n=1062 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Age, Continuous	41.2 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	686 Participants n=5 Participants
Sex: Female, Male Male	376 Participants n=5 Participants
Race/Ethnicity, Customized White	988 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	34 Participants n=5 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska native	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline until the end of the study (up to a maximum duration of 5.6 years)

Population: Analysis was performed on safety analysis set that included all participants who signed the informed consent form (ICF). As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 [i.e. up to a maximum of 5.6 years]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=1062 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) Any TEAE	204 Participants	500 Participants	879 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) Any TESAE	55 Participants	133 Participants	237 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) Any TEAE leading to death	0 Participants	10 Participants	11 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) Any TEAE leading to permanent treatment discontinuation	0 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Within 24 hours of any alemtuzumab infusion

Population: Analysis was performed on re-treated population that included all participants who had signed the ICF and who had received study drug in the current study LPS13649. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=83 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=164 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=294 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Number of Participants With Infusion-Associated Reactions (IAR)	48 Participants	89 Participants	164 Participants

PRIMARY outcome

Timeframe: From Baseline until the end of the study (up to a maximum duration of 5.6 years)

Population: Analysis was performed on safety population. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=1062 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Number of Participants With Adverse Events of Special Interest (AESI) Hypersensitivity or anaphylaxis	12 Participants	25 Participants	44 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Pregnancy of a woman entered in the study	17 Participants	42 Participants	70 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Symptomatic overdose (serious or non-serious) with IMP	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Increase in ALT	0 Participants	0 Participants	1 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Autoimmune mediated conditions	27 Participants	66 Participants	100 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Hemophagocytic lymphohistiocytosis	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Progressive multifocal leukoencephalopathy	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Temporally associated AEs	2 Participants	4 Participants	9 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Serious infections	10 Participants	35 Participants	60 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Malignancy	6 Participants	15 Participants	27 Participants
Number of Participants With Adverse Events of Special Interest (AESI) Pneumonitis	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Baseline until the end of the study (up to a maximum duration of 5.6 years)

Population: Analysis was performed on all participants who had signed the ICF; and received study drug in the TOPAZ study; or in studies CAMMS223,CAMMS323,CAMMS324 or CAMMS03409, and did not complete 48 months of follow-up at the screening visit in the TOPAZ study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.

Criteria for potentially clinically significant laboratory abnormalities included:

• Hemoglobin (Hb): less than or equal to (<=)115 grams per liter (g/L)(Male [M]), <= 95 g/L (Female[ F]); greater than or equal to (>=)185 g/L (M), >= 165 g/L (F); Decrease From Baseline (DFB) >= 20 g/L.
• Hematocrit: <= 0.37 volume/volume (v/v) (M); <= 0.32 v/v (F); >= 0.55 v/v (M); >= 0.5 v/v (F).
• Red Blood Cells (RBCs): >=6 *10^12/L.
• Platelets: <100 *10^9/L; >=700 *10^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=214 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=316 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=619 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities Hb:<=115 g/L, <=95 g/L	11 Participants	28 Participants	43 Participants
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities Hb: >=185 g/L, >=165 g/L	2 Participants	6 Participants	12 Participants
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities Hb: DFB >=20 g/L	32 Participants	50 Participants	98 Participants
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities Hematocrit: <= 0.37 v/v; <=0.32 v/v	20 Participants	42 Participants	70 Participants
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities Hematocrit: >=0.55 v/v; >=0.5 v/v	6 Participants	14 Participants	26 Participants
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities RBCs: >=6 *10^12/L	8 Participants	7 Participants	21 Participants
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities Platelets: <100 *10^9/L	5 Participants	16 Participants	25 Participants
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities Platelets: >=700 *10^9/L	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to a maximum duration of 5.6 years

Population: Analysis was performed on efficacy population which included all enrolled participants who had received study drug in studies CAMMS223, CAMMS323, CAMMS324 or CAMMS03409. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Annualized Relapse Rate	0.1994 relapses per participant per year Interval 0.171 to 0.2325	0.1608 relapses per participant per year Interval 0.1418 to 0.1823	—

SECONDARY outcome

Timeframe: Up to a maximum duration of 5.6 years

Population: Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. The proportion of participants who were relapse free (without event) were estimated using the Kaplan-Meier method.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Proportion of Participants Who Were Relapse Free	29.59 proportion of participants Interval 23.73 to 35.65	36.86 proportion of participants Interval 32.96 to 40.76	—

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Population: Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 6	0.21 score on a scale Standard Error 0.092	0.03 score on a scale Standard Error 0.065	—
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 12	0.27 score on a scale Standard Error 0.093	0.08 score on a scale Standard Error 0.065	—
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 18	0.29 score on a scale Standard Error 0.096	0.10 score on a scale Standard Error 0.067	—
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 24	0.28 score on a scale Standard Error 0.102	0.15 score on a scale Standard Error 0.070	—
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 30	0.34 score on a scale Standard Error 0.102	0.16 score on a scale Standard Error 0.071	—
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 36	0.38 score on a scale Standard Error 0.103	0.18 score on a scale Standard Error 0.071	—
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 42	0.37 score on a scale Standard Error 0.103	0.24 score on a scale Standard Error 0.071	—
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 48	0.46 score on a scale Standard Error 0.104	0.27 score on a scale Standard Error 0.072	—
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 54	0.51 score on a scale Standard Error 0.106	0.30 score on a scale Standard Error 0.074	—
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 Month 60	0.43 score on a scale Standard Error 0.129	0.32 score on a scale Standard Error 0.088	—

SECONDARY outcome

Timeframe: Up to a maximum duration of 5.6 years

Population: Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

Number of Gd-enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with generalized estimating equation (GEE) adjusted for analysis groups and geographic region as covariates.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan	1.307 lesions per scan Interval 0.88 to 1.941	1.558 lesions per scan Interval 1.153 to 2.105	—

SECONDARY outcome

Timeframe: Up to a maximum duration of 5.6 years

Population: Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan	8.033 lesions per scan Interval 6.001 to 10.753	9.564 lesions per scan Interval 7.656 to 11.946	—

SECONDARY outcome

Timeframe: Up to a maximum duration of 5.6 years

Population: Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

Number of new T1 lesions per scan was defined as the total number of new T1 lesion (and New Hypointense T1) that occurred during treatment period divided by the total number of scans performed during treatment period.The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan	1.719 lesions per scan Interval 1.141 to 2.589	1.908 lesions per scan Interval 1.386 to 2.628	—

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was preformed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

The total lesion volume (T1 lesions) was measured by MRI scan.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60 Month 12	141.71 percent change Standard Deviation 449.79	64.73 percent change Standard Deviation 241.92	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60 Month 24	130.73 percent change Standard Deviation 398.65	67.48 percent change Standard Deviation 262.64	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60 Month 36	145.57 percent change Standard Deviation 404.35	104.41 percent change Standard Deviation 524.62	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60 Month 48	163.30 percent change Standard Deviation 461.38	76.90 percent change Standard Deviation 312.05	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60 Month 60	202.47 percent change Standard Deviation 499.46	93.61 percent change Standard Deviation 260.51	—

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

The total lesion volume (T2 lesions) was measured by MRI scan.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60 Month 48	21.98 percent change Standard Deviation 80.06	19.46 percent change Standard Deviation 70.72	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60 Month 12	21.44 percent change Standard Deviation 132.04	9.09 percent change Standard Deviation 62.52	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60 Month 24	17.53 percent change Standard Deviation 76.73	13.89 percent change Standard Deviation 62.45	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60 Month 36	24.24 percent change Standard Deviation 94.85	22.02 percent change Standard Deviation 111.95	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60 Month 60	32.03 percent change Standard Deviation 136.68	17.95 percent change Standard Deviation 75.47	—

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

The brain parenchymal fraction was measured by MRI scan.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60 Month 12	-1.65 percent change Standard Deviation 1.59	-1.49 percent change Standard Deviation 1.55	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60 Month 24	-1.77 percent change Standard Deviation 1.56	-1.68 percent change Standard Deviation 1.64	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60 Month 36	-1.92 percent change Standard Deviation 1.56	-1.84 percent change Standard Deviation 1.71	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60 Month 48	-2.02 percent change Standard Deviation 1.58	-2.07 percent change Standard Deviation 1.78	—
Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60 Month 60	-2.11 percent change Standard Deviation 1.67	-2.37 percent change Standard Deviation 1.65	—

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

The MOS SF-36 is an extensively validated and widely used measure of QoL that assesses participants' perceptions of health status and its impact on their lives. It consisted of 36 items organized into 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health). Two summary measures of physical and mental health, the PCS and MCS, respectively, were derived from scale aggregates, and were reported in this outcome measure. The score range for each of these 2 summary scores was from 0 (worst) to 100 (best), higher scores indicated better QoL.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 PCS: Month 12	0.54 score on a scale Standard Deviation 9.38	0.88 score on a scale Standard Deviation 8.72	—
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 PCS: Month 24	0.20 score on a scale Standard Deviation 9.25	0.59 score on a scale Standard Deviation 9.10	—
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 PCS: Month 36	0.08 score on a scale Standard Deviation 9.88	1.12 score on a scale Standard Deviation 9.18	—
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 PCS: Month 48	-0.52 score on a scale Standard Deviation 10.15	0.68 score on a scale Standard Deviation 9.57	—
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 PCS: Month 60	-0.23 score on a scale Standard Deviation 8.85	1.28 score on a scale Standard Deviation 8.88	—
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 MCS: Month 12	2.21 score on a scale Standard Deviation 12.29	0.89 score on a scale Standard Deviation 11.24	—
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 MCS: Month 24	1.21 score on a scale Standard Deviation 12.23	1.11 score on a scale Standard Deviation 11.93	—
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 MCS: Month 36	1.55 score on a scale Standard Deviation 12.23	0.94 score on a scale Standard Deviation 11.88	—
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 MCS: Month 48	1.14 score on a scale Standard Deviation 12.93	0.35 score on a scale Standard Deviation 12.38	—
Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60 MCS: Month 60	0.94 score on a scale Standard Deviation 14.01	0.45 score on a scale Standard Deviation 11.39	—

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

The FAMS is a self-reported multidimensional index comprising a total of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Each item (except those for "additional concerns") was rated on a 5-point scale of 0 (lower quality of life) to 4 (higher quality of life). Total FAMS score was the sum of 44 scored items, which ranged from 0 (poor) to 176 (best), with higher numbers reflecting a higher quality of life.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60 Month 12	1.05 score on a scale Standard Deviation 29.68	2.83 score on a scale Standard Deviation 27.07	—
Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60 Month 24	-0.45 score on a scale Standard Deviation 30.30	2.73 score on a scale Standard Deviation 28.62	—
Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60 Month 36	0.82 score on a scale Standard Deviation 30.52	2.70 score on a scale Standard Deviation 28.94	—
Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60 Month 48	-3.73 score on a scale Standard Deviation 31.46	1.16 score on a scale Standard Deviation 29.38	—
Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60 Month 60	-0.36 score on a scale Standard Deviation 31.25	2.74 score on a scale Standard Deviation 26.61	—

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

The EQ-5D is a generic, standardized instrument that provides a simple, descriptive profile and a single index value for health status used in the clinical and economic evaluation of health care as well as in population health surveys. The EQ-5D comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: some, moderate, and extreme problems. The 5 dimensional 3-level systems was converted into single index utility score ranges from 0 to 100, where 100=best health state; and 0=worst health state; higher scores indicated better outcome.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60 Month 24	-0.02 score on a scale Standard Deviation 0.28	-0.01 score on a scale Standard Deviation 0.26	—
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60 Month 12	-0.01 score on a scale Standard Deviation 0.26	-0.01 score on a scale Standard Deviation 0.26	—
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60 Month 36	-0.04 score on a scale Standard Deviation 0.27	-0.00 score on a scale Standard Deviation 0.26	—
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60 Month 48	-0.03 score on a scale Standard Deviation 0.27	-0.03 score on a scale Standard Deviation 0.27	—
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60 Month 60	-0.03 score on a scale Standard Deviation 0.29	-0.03 score on a scale Standard Deviation 0.25	—

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).

EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0 to 100), where 0=worst imaginable health state to 100=best imaginable health state, and higher score indicated better outcome.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60 Month 48	-1.08 score on a scale Standard Deviation 23.66	-0.85 score on a scale Standard Deviation 23.94	—
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60 Month 12	-2.09 score on a scale Standard Deviation 25.11	-1.05 score on a scale Standard Deviation 24.57	—
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60 Month 24	-1.57 score on a scale Standard Deviation 26.69	-0.39 score on a scale Standard Deviation 21.44	—
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60 Month 36	0.10 score on a scale Standard Deviation 22.61	1.42 score on a scale Standard Deviation 20.64	—
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60 Month 60	-3.26 score on a scale Standard Deviation 27.04	-0.77 score on a scale Standard Deviation 26.26	—

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS. Questionnaire addresses the following content areas: employment situation and changes in employment situation due to MS;sick leaves,admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments (eg, stair and bed lift, ramps,rails) and devices (eg,walking aids,wheelchairs); assistance by community or social services (e.g. home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported "Yes" as an answer to "employment situation change; had sick leaves; had hospital admission; had spent time in rehabilitation center and had spent time in a nursing home or a similar institution" questions were reported in this outcome measure.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=231 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=573 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=1020 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Employment situation change: Month 0	3 Participants	7 Participants	12 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Employment situation change: Month 12	11 Participants	25 Participants	44 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Employment situation change: Month 24	14 Participants	19 Participants	40 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Employment situation change: Month 36	12 Participants	26 Participants	44 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Employment situation change: Month 48	4 Participants	24 Participants	38 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Employment situation change: Month 60	3 Participants	8 Participants	14 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had sick leaves: Month 0	6 Participants	14 Participants	21 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had sick leaves: Month 12	19 Participants	45 Participants	77 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had sick leaves: Month 24	23 Participants	42 Participants	80 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had sick leaves: Month 36	21 Participants	44 Participants	78 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had sick leaves: Month 48	18 Participants	31 Participants	60 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had sick leaves: Month 60	9 Participants	10 Participants	25 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had hospital admission: Month 0	4 Participants	23 Participants	32 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had hospital admission: Month 12	28 Participants	59 Participants	109 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had hospital admission: Month 24	26 Participants	53 Participants	95 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had hospital admission: Month 36	27 Participants	58 Participants	106 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had hospital admission: Month 48	20 Participants	51 Participants	89 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had hospital admission: Month 60	12 Participants	11 Participants	28 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in rehabilitation center: Month 0	0 Participants	6 Participants	8 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in rehabilitation center: Month 12	12 Participants	21 Participants	45 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in rehabilitation center: Month 24	17 Participants	18 Participants	45 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in rehabilitation center: Month 36	12 Participants	19 Participants	36 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in rehabilitation center: Month 48	12 Participants	24 Participants	45 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in rehabilitation center: Month 60	5 Participants	6 Participants	18 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in a nursing home: Month 0	0 Participants	0 Participants	0 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in a nursing home: Month 12	0 Participants	5 Participants	8 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in a nursing home: Month 24	3 Participants	4 Participants	7 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in a nursing home: Month 36	3 Participants	3 Participants	8 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in a nursing home: Month 48	4 Participants	4 Participants	11 Participants
Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis Had spent time in a nursing home: Month 60	0 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS.Questionnaire addresses following content areas: employment situation and changes in employment situation due to MS; admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments(e.g.stair and bed lift,ramps,rails) and devices(e.g.walking aids,wheelchairs);assistance by community or social services(e.g.home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported other changes/changes in lifestyle due to MS, i.e."Yes" as an answer to "had made changes to your house, apartment, car or did you require any special equipment or aids; assistance required; other assistance required" questions were reported in this outcome measure.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=231 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=573 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=1020 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had made changes to your house, apartment, car: Month 0	0 Participants	3 Participants	7 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had made changes to your house, apartment, car: Month 12	11 Participants	21 Participants	42 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had made changes to your house, apartment, car: Month 24	10 Participants	25 Participants	47 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had made changes to your house, apartment, car: Month 36	16 Participants	15 Participants	45 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had made changes to your house, apartment, car: Month 48	10 Participants	25 Participants	42 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had made changes to your house, apartment, car: Month 60	5 Participants	3 Participants	12 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required assistance: Month 0	4 Participants	10 Participants	24 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required assistance: Month 12	24 Participants	45 Participants	88 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required assistance: Month 24	26 Participants	44 Participants	86 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required assistance: Month 36	22 Participants	35 Participants	79 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required assistance: Month 48	12 Participants	45 Participants	75 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required assistance: Month 60	8 Participants	10 Participants	26 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required other assistance: Month 0	15 Participants	48 Participants	77 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required other assistance: Month 12	57 Participants	144 Participants	252 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required other assistance: Month 24	57 Participants	135 Participants	241 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required other assistance: Month 36	48 Participants	119 Participants	215 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required other assistance: Month 48	49 Participants	119 Participants	211 Participants
Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis Had required other assistance: Month 60	22 Participants	27 Participants	66 Participants

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Current employment status of participants (i.e. Part Time/Full Time/Not Employed) was reported in this outcome measure.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=234 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=575 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=1025 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Full time: Month 0	127 Participants	297 Participants	528 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Part time: Month 12	20 Participants	53 Participants	104 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Full time: Month 24	118 Participants	273 Participants	488 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Part time: Month 0	20 Participants	54 Participants	98 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Not employed: Month 0	87 Participants	224 Participants	399 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Full time: Month 12	121 Participants	291 Participants	511 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Not employed: Month 12	88 Participants	225 Participants	398 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Part time: Month 24	21 Participants	66 Participants	117 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Not employed: Month 24	84 Participants	210 Participants	375 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Full time: Month 36	109 Participants	273 Participants	478 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Part time: Month 36	23 Participants	57 Participants	108 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Not employed: Month 36	84 Participants	200 Participants	357 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Full time: Month 48	108 Participants	225 Participants	424 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Part time: Month 48	21 Participants	57 Participants	103 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Not employed: Month 48	75 Participants	187 Participants	333 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Full time: Month 60	37 Participants	97 Participants	189 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Part time: Month 60	10 Participants	18 Participants	43 Participants
Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis Not employed: Month 60	35 Participants	68 Participants	142 Participants

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled working hours of participants; number of hours missed from work by participants due to MS" were reported in this outcome measure.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=153 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=380 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=675 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Total scheduled working hours: Month 24	33.2 hours Standard Deviation 15.5	30.8 hours Standard Deviation 16.1	31.6 hours Standard Deviation 16.1
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Total scheduled working hours: Month 36	33.6 hours Standard Deviation 16.4	33.1 hours Standard Deviation 15.1	33.3 hours Standard Deviation 15.3
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Total scheduled working hours: Month 60	27.3 hours Standard Deviation 18.9	31.1 hours Standard Deviation 15.8	31.1 hours Standard Deviation 16.6
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Number of hours missed from work: Month 24	6.7 hours Standard Deviation 6.1	10.6 hours Standard Deviation 11.3	10.4 hours Standard Deviation 10.9
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Number of hours missed from work: Month 36	9.3 hours Standard Deviation 5.9	24.7 hours Standard Deviation 65.4	18.7 hours Standard Deviation 50.8
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Number of hours missed from work: Month 48	21.5 hours Standard Deviation 23.1	37.7 hours Standard Deviation 107.6	28.0 hours Standard Deviation 77.1
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Number of hours missed from work: Month 60	14.5 hours Standard Deviation 13.4	13.4 hours Standard Deviation 13.4	13.9 hours Standard Deviation 13.0
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Total scheduled working hours: Month 0	34.0 hours Standard Deviation 14.6	32.2 hours Standard Deviation 16.1	32.9 hours Standard Deviation 16.1
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Total scheduled working hours: Month 12	33.6 hours Standard Deviation 15.4	32.3 hours Standard Deviation 16.6	32.5 hours Standard Deviation 16.6
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Total scheduled working hours: Month 48	34.4 hours Standard Deviation 19.7	31.3 hours Standard Deviation 16.3	32.9 hours Standard Deviation 17.0
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Number of hours missed from work: Month 0	9.8 hours Standard Deviation 12.1	15.2 hours Standard Deviation 15.0	11.7 hours Standard Deviation 12.8
HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis Number of hours missed from work: Month 12	6.7 hours Standard Deviation 3.6	10.1 hours Standard Deviation 12.2	9.0 hours Standard Deviation 10.2

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output due to MS were reported in this outcome measure.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=145 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=351 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=622 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis Month 0	6.2 percentage impact on work output Standard Deviation 14.4	10.2 percentage impact on work output Standard Deviation 22.3	8.5 percentage impact on work output Standard Deviation 19.5
HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis Month 12	8.7 percentage impact on work output Standard Deviation 18.0	9.5 percentage impact on work output Standard Deviation 21.5	9.0 percentage impact on work output Standard Deviation 20.2
HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis Month 24	9.9 percentage impact on work output Standard Deviation 20.4	9.4 percentage impact on work output Standard Deviation 21.2	9.8 percentage impact on work output Standard Deviation 21.3
HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis Month 36	9.2 percentage impact on work output Standard Deviation 20.0	9.9 percentage impact on work output Standard Deviation 21.3	9.4 percentage impact on work output Standard Deviation 19.9
HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis Month 48	12.2 percentage impact on work output Standard Deviation 25.4	9.3 percentage impact on work output Standard Deviation 21.7	9.7 percentage impact on work output Standard Deviation 22.0
HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis Month 60	11.7 percentage impact on work output Standard Deviation 22.3	8.1 percentage impact on work output Standard Deviation 18.9	9.2 percentage impact on work output Standard Deviation 19.9

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population.Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled household chores hours; number of hours missed from planned household chores by participants due to MS" were reported in this outcome measure.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=228 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=562 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=1004 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Total scheduled household chores hours: Month 12	10.3 hours Standard Deviation 10.1	11.1 hours Standard Deviation 11.7	10.9 hours Standard Deviation 11.5
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Number of hours missed from household chores: Month 12	4.9 hours Standard Deviation 3.5	6.8 hours Standard Deviation 7.7	6.2 hours Standard Deviation 6.6
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Number of hours missed from household chores: Month 24	7.8 hours Standard Deviation 9.0	7.1 hours Standard Deviation 10.6	6.6 hours Standard Deviation 9.3
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Number of hours missed from household chores: Month 0	4.7 hours Standard Deviation 3.3	6.5 hours Standard Deviation 6.9	6.0 hours Standard Deviation 5.9
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Total scheduled household chores hours: Month 0	9.8 hours Standard Deviation 8.3	11.0 hours Standard Deviation 11.0	10.8 hours Standard Deviation 10.6
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Total scheduled household chores hours: Month 24	10.2 hours Standard Deviation 11.6	10.9 hours Standard Deviation 11.4	10.6 hours Standard Deviation 11.4
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Total scheduled household chores hours: Month 36	9.7 hours Standard Deviation 10.2	11.7 hours Standard Deviation 13.1	11.0 hours Standard Deviation 12.1
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Total scheduled household chores hours: Month 48	9.9 hours Standard Deviation 8.9	10.5 hours Standard Deviation 10.6	10.3 hours Standard Deviation 10.3
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Total scheduled household chores hours: Month 60	10.4 hours Standard Deviation 8.7	11.2 hours Standard Deviation 11.1	11.5 hours Standard Deviation 12.6
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Number of hours missed from household chores: Month 36	6.1 hours Standard Deviation 7.4	7.7 hours Standard Deviation 14.2	7.0 hours Standard Deviation 11.7
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Number of hours missed from household chores: Month 48	4.8 hours Standard Deviation 4.3	6.2 hours Standard Deviation 10.6	5.7 hours Standard Deviation 8.4
HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis Number of hours missed from household chores: Month 60	5.3 hours Standard Deviation 5.2	5.8 hours Standard Deviation 5.1	5.9 hours Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60

Population: Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output for household chores due to MS were reported in this outcome measure.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=212 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=531 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=947 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis Month 36	17.5 percentage impact on work output Standard Deviation 25.9	16.5 percentage impact on work output Standard Deviation 26.2	17.6 percentage impact on work output Standard Deviation 26.6
HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis Month 60	18.8 percentage impact on work output Standard Deviation 28.3	13.1 percentage impact on work output Standard Deviation 22.9	14.8 percentage impact on work output Standard Deviation 25.0
HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis Month 0	16.0 percentage impact on work output Standard Deviation 23.8	16.4 percentage impact on work output Standard Deviation 26.0	16.8 percentage impact on work output Standard Deviation 25.8
HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis Month 12	18.3 percentage impact on work output Standard Deviation 27.3	16.6 percentage impact on work output Standard Deviation 26.6	17.7 percentage impact on work output Standard Deviation 27.5
HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis Month 24	20.3 percentage impact on work output Standard Deviation 28.5	18.5 percentage impact on work output Standard Deviation 27.4	19.4 percentage impact on work output Standard Deviation 28.1
HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis Month 48	19.8 percentage impact on work output Standard Deviation 28.8	17.0 percentage impact on work output Standard Deviation 26.8	18.6 percentage impact on work output Standard Deviation 27.7

SECONDARY outcome

Timeframe: Baseline up to end of the study (up to a maximum duration of 5.6 years)

Population: Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Mean and standard deviation data for duration of MS disease (in months) since the start of MS development in participants was reported in this outcome measure.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=228 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=559 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=997 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis	10.3 months Standard Deviation 4.0	10.2 months Standard Deviation 5.0	10.5 months Standard Deviation 4.5

SECONDARY outcome

Timeframe: Baseline up to end of the study (up to a maximum duration of 5.6 years)

Population: Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Number of participants who reported "Yes" as an answer to questions related to impact on work: "forced me to work part-time when I wanted to work full-time; kept me from having a job when I wanted to work full-time; kept me from having a job when I wanted to work part-time; none of the above" questions were reported in this outcome measure.

Outcome measures

Measure	Delayed Alemtuzumab Treatment (DAT) n=164 Participants Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=399 Participants Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=709 Participants All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis My MS or treatments forced me to work part-time when I wanted to work full-time	22 Participants	81 Participants	125 Participants
HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis My MS or treatments kept me from having a job when I wanted to work full-time	32 Participants	88 Participants	168 Participants
HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis My MS or treatments kept me from having a job when I wanted to work part-time	20 Participants	42 Participants	81 Participants
HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis None of the above	164 Participants	399 Participants	709 Participants

Adverse Events

Delayed Alemtuzumab Treatment (DAT)

Serious events: 55 serious events

Other events: 150 other events

Deaths: 0 deaths

Initial Alemtuzumab Treatment (IAT)

Serious events: 133 serious events

Other events: 338 other events

Deaths: 10 deaths

Alemtuzumab

Serious events: 237 serious events

Other events: 601 other events

Deaths: 11 deaths

Serious adverse events

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 participants at risk Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 participants at risk Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=1062 participants at risk All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Blood and lymphatic system disorders Immune Thrombocytopenia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Blood and lymphatic system disorders Thrombocytopenia	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Acute Left Ventricular Failure	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Acute Myocardial Infarction	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.38% 4/1062 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Atrioventricular Block	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Bundle Branch Block Left	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Coronary Artery Disease	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Left Ventricular Dysfunction	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Mitral Valve Incompetence	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Myocardial Infarction	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Pericardial Effusion	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Sinus Tachycardia	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Cardiac disorders Ventricular Arrhythmia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Congenital, familial and genetic disorders Atrial Septal Defect	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Congenital, familial and genetic disorders Congenital Cystic Kidney Disease	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Congenital, familial and genetic disorders Congenital Nail Disorder	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Congenital, familial and genetic disorders Foetal Chromosome Abnormality	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Congenital, familial and genetic disorders Trisomy 21	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Ear and labyrinth disorders Haematotympanum	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Ear and labyrinth disorders Vertigo	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Endocrine disorders Autoimmune Hypothyroidism	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Endocrine disorders Autoimmune Thyroid Disorder	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Endocrine disorders Autoimmune Thyroiditis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Endocrine disorders Basedow's Disease	0.83% 2/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.67% 4/598 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.66% 7/1062 • Number of events 7 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Endocrine disorders Hyperthyroidism	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Endocrine disorders Hypothyroidism	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Endocrine disorders Thyroid Dermatopathy	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Eye disorders Cataract	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Eye disorders Endocrine Ophthalmopathy	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Eye disorders Exophthalmos	0.41% 1/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Eye disorders Eyelid Ptosis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Eye disorders Glaucoma	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Eye disorders Optic Ischaemic Neuropathy	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Eye disorders Periorbital Oedema	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Diarrhoea	0.41% 1/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Gastric Ulcer Perforation	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Gastritis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Haematemesis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Haemorrhoids	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Inguinal Hernia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Intestinal Ischaemia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Intussusception	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Obstructive Pancreatitis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Pancreatitis Acute	0.83% 2/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Pancreatitis Chronic	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
General disorders Catheter Site Pain	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
General disorders Complication Associated With Device	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
General disorders Death	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
General disorders Drug Intolerance	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
General disorders Hyperthermia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
General disorders Non-Cardiac Chest Pain	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
General disorders Pyrexia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
General disorders Sudden Death	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Hepatobiliary disorders Cholecystitis	0.83% 2/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Hepatobiliary disorders Cholelithiasis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.38% 4/1062 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Immune system disorders Drug Hypersensitivity	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Immune system disorders Immune Reconstitution Inflammatory Syndrome	0.41% 1/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Immune system disorders Sarcoidosis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Abdominal Abscess	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Abscess Rupture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Anal Abscess	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Appendicitis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Bacteraemia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Bacterial Sepsis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Cellulitis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.50% 3/598 • Number of events 7 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.38% 4/1062 • Number of events 8 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Cellulitis Staphylococcal	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Clostridium Difficile Colitis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Clostridium Difficile Infection	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Diverticulitis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Endocarditis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Erysipelas	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Escherichia Urinary Tract Infection	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Gangrene	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Gastroenteritis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Gastrointestinal Bacterial Infection	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Herpes Zoster	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.50% 3/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Herpes Zoster Infection Neurological	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Infected Bite	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Infected Lymphocele	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Influenza	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Klebsiella Infection	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Localised Infection	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Neonatal Pneumonia	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Osteomyelitis Acute	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Periodontitis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Pneumonia	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.67% 4/598 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.85% 9/1062 • Number of events 10 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Pneumonia Bacterial	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Pneumonia Streptococcal	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Postoperative Wound Infection	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Pyelonephritis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Scrotal Abscess	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Sepsis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.47% 5/1062 • Number of events 7 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Septic Shock	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.50% 3/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.38% 4/1062 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Urinary Tract Infection	0.83% 2/241 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.67% 4/598 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.85% 9/1062 • Number of events 10 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Urinary Tract Infection Bacterial	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Urosepsis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Uterine Infection	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Accidental Overdose	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Brain Contusion	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Burns Third Degree	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Face Injury	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Fall	0.41% 1/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Femur Fracture	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Head Injury	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Humerus Fracture	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Induced Abortion Failed	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Intentional Overdose	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Meniscus Injury	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Post Procedural Hypotension	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Skull Fractured Base	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Subdural Haematoma	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Tibia Fracture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Traumatic Fracture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Ulna Fracture	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Upper Limb Fracture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Investigations Antiphospholipid Antibodies Positive	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Investigations Human Papilloma Virus Test Positive	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Investigations Lymphocyte Count Decreased	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Metabolism and nutrition disorders Dehydration	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Metabolism and nutrition disorders Diabetic Ketosis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Metabolism and nutrition disorders Electrolyte Imbalance	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Metabolism and nutrition disorders Hyperglycaemia	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Metabolism and nutrition disorders Type 1 Diabetes Mellitus	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.50% 3/598 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Musculoskeletal and connective tissue disorders Joint Contracture	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Musculoskeletal and connective tissue disorders Systemic Lupus Erythematosus	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brenner Tumour	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma Stage 0	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cutaneous T-Cell Lymphoma	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder Cancer Stage Iii	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal Proliferative Breast Lesion	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Lobular Breast Carcinoma	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Squamous Cell Carcinoma	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Squamous Cell Carcinoma Stage Iii	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma In Situ	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Of Unknown Primary Site	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Germ Cell Teratoma	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer Metastatic	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Skin	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Cancer	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.50% 3/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.47% 5/1062 • Number of events 5 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Ataxia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Dizziness	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Dysarthria	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Encephalopathy	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Epilepsy	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Generalised Tonic-Clonic Seizure	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Headache	0.83% 2/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Limbic Encephalitis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Loss Of Consciousness	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Lumbosacral Radiculopathy	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Multiple Sclerosis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Multiple Sclerosis Relapse	2.5% 6/241 • Number of events 6 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	3.0% 18/598 • Number of events 30 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	2.8% 30/1062 • Number of events 43 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Optic Neuritis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Partial Seizures	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Post Herpetic Neuralgia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Postural Tremor	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Resting Tremor	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Sciatica	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Seizure	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Syncope	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Toxic Encephalopathy	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Trigeminal Neuralgia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Uhthoff's Phenomenon	1.2% 3/241 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.84% 5/598 • Number of events 5 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.85% 9/1062 • Number of events 9 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Abortion Missed	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	1.2% 3/241 • Number of events 5 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	1.0% 6/598 • Number of events 7 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	1.0% 11/1062 • Number of events 15 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Anembryonic Gestation	0.41% 1/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Foetal Distress Syndrome	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Hellp Syndrome	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Missed Labour	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Pre-Eclampsia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Pregnancy	0.83% 2/241 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.67% 4/598 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.66% 7/1062 • Number of events 8 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Prolonged Labour	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Alcoholism	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Behaviour Disorder	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Completed Suicide	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Confusional State	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Depression	0.83% 2/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.38% 4/1062 • Number of events 4 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Depression Suicidal	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Drug Abuse	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Major Depression	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Mental Disorder	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Substance-Induced Psychotic Disorder	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Suicidal Ideation	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Suicide Attempt	0.83% 2/241 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.38% 4/1062 • Number of events 5 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Renal and urinary disorders Acute Kidney Injury	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Renal and urinary disorders Cystitis Haemorrhagic	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Renal and urinary disorders Lupus Nephritis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Renal and urinary disorders Nephrolithiasis	0.83% 2/241 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.47% 5/1062 • Number of events 7 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Renal and urinary disorders Renal Colic	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Renal and urinary disorders Renal Injury	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Reproductive system and breast disorders Cervical Dysplasia	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.50% 3/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.47% 5/1062 • Number of events 5 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Reproductive system and breast disorders Cystocele	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Reproductive system and breast disorders Endometriosis	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Reproductive system and breast disorders Female Genital Tract Fistula	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Reproductive system and breast disorders Menorrhagia	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Reproductive system and breast disorders Metrorrhagia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Reproductive system and breast disorders Uterine Polyp	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Reproductive system and breast disorders Vaginal Haemorrhage	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Respiratory, thoracic and mediastinal disorders Asthma	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Respiratory, thoracic and mediastinal disorders Organising Pneumonia	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.50% 3/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.28% 3/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 3 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Skin and subcutaneous tissue disorders Erythema	0.41% 1/241 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Skin and subcutaneous tissue disorders Rash	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Vascular disorders Deep Vein Thrombosis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.17% 1/598 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Vascular disorders Flushing	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Vascular disorders Hypertension	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.00% 0/598 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.09% 1/1062 • Number of events 1 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Vascular disorders Peripheral Artery Thrombosis	0.00% 0/241 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.33% 2/598 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	0.19% 2/1062 • Number of events 2 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).

Other adverse events

Measure	Delayed Alemtuzumab Treatment (DAT) n=241 participants at risk Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Initial Alemtuzumab Treatment (IAT) n=598 participants at risk Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).	Alemtuzumab n=1062 participants at risk All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
Gastrointestinal disorders Nausea	5.4% 13/241 • Number of events 13 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	3.0% 18/598 • Number of events 18 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	3.5% 37/1062 • Number of events 37 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
General disorders Fatigue	6.2% 15/241 • Number of events 17 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	3.2% 19/598 • Number of events 19 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.0% 43/1062 • Number of events 45 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Bronchitis	5.8% 14/241 • Number of events 17 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	7.4% 44/598 • Number of events 54 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	6.3% 67/1062 • Number of events 81 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Herpes Zoster	6.2% 15/241 • Number of events 16 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.8% 29/598 • Number of events 35 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.7% 50/1062 • Number of events 57 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Influenza	5.4% 13/241 • Number of events 13 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.2% 25/598 • Number of events 28 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.5% 48/1062 • Number of events 55 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Nasopharyngitis	14.1% 34/241 • Number of events 60 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	12.2% 73/598 • Number of events 112 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	12.1% 129/1062 • Number of events 204 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Sinusitis	4.6% 11/241 • Number of events 11 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	5.7% 34/598 • Number of events 45 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	5.4% 57/1062 • Number of events 71 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Upper Respiratory Tract Infection	11.2% 27/241 • Number of events 29 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	8.4% 50/598 • Number of events 73 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	9.0% 96/1062 • Number of events 123 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Infections and infestations Urinary Tract Infection	15.4% 37/241 • Number of events 56 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	13.0% 78/598 • Number of events 143 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	14.2% 151/1062 • Number of events 271 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Injury, poisoning and procedural complications Fall	6.2% 15/241 • Number of events 20 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.5% 27/598 • Number of events 34 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	5.1% 54/1062 • Number of events 74 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 19/241 • Number of events 27 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	6.5% 39/598 • Number of events 45 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	6.5% 69/1062 • Number of events 86 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Musculoskeletal and connective tissue disorders Back Pain	6.6% 16/241 • Number of events 16 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	5.0% 30/598 • Number of events 34 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	5.8% 62/1062 • Number of events 68 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Nervous system disorders Headache	15.4% 37/241 • Number of events 52 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	11.2% 67/598 • Number of events 87 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	11.8% 125/1062 • Number of events 164 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Pregnancy, puerperium and perinatal conditions Pregnancy	5.8% 14/241 • Number of events 23 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	6.5% 39/598 • Number of events 46 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	5.9% 63/1062 • Number of events 86 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Depression	5.4% 13/241 • Number of events 13 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.2% 25/598 • Number of events 26 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.0% 43/1062 • Number of events 45 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Psychiatric disorders Insomnia	6.6% 16/241 • Number of events 17 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.8% 29/598 • Number of events 32 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	5.4% 57/1062 • Number of events 62 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).
Skin and subcutaneous tissue disorders Rash	5.4% 13/241 • Number of events 16 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.3% 26/598 • Number of events 34 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).	4.8% 51/1062 • Number of events 64 • All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years). Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).

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