Trial Outcomes & Findings for Prospective Observational Epidemiologic Study of Maraviroc's Safety (NCT NCT00665561)

NCT ID: NCT00665561

Last Updated: 2022-10-18

Results Overview

Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).

• Recruitment status: COMPLETED
• Target enrollment: 2500 participants
• Primary outcome timeframe: Up to 5 years following enrollment
• Results posted on: 2022-10-18

Participant Flow

Study was conducted at multiple sites between 31 March 2008 and 14 February 2019.

Participant milestones

Measure	Maraviroc Exposed Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Unexposed HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Overall Study STARTED	1316	1130
Overall Study COMPLETED	814	596
Overall Study NOT COMPLETED	502	534

Reasons for withdrawal

Measure	Maraviroc Exposed Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Unexposed HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Overall Study Death recorded on subject summary pages	75	75
Overall Study Does not meet entrance criteria	19	21
Overall Study Lost to Follow-up	203	264
Overall Study Withdrawal by Subject	74	65
Overall Study Other	123	108
Overall Study Site closed	8	0
Overall Study Withdrawn due to pregnancy	0	1

Baseline Characteristics

Prospective Observational Epidemiologic Study of Maraviroc's Safety

Baseline characteristics by cohort

Measure	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Total n=2446 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 9.3 • n=5 Participants	44.3 years STANDARD_DEVIATION 10.0 • n=7 Participants	45.6 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	275 Participants n=5 Participants	265 Participants n=7 Participants	540 Participants n=5 Participants
Sex: Female, Male Male	1041 Participants n=5 Participants	865 Participants n=7 Participants	1906 Participants n=5 Participants
Race/Ethnicity, Customized White	983 Participants n=5 Participants	684 Participants n=7 Participants	1667 Participants n=5 Participants
Race/Ethnicity, Customized Black	271 Participants n=5 Participants	390 Participants n=7 Participants	661 Participants n=5 Participants
Race/Ethnicity, Customized Asian	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Other	48 Participants n=5 Participants	48 Participants n=7 Participants	96 Participants n=5 Participants
Race/Ethnicity, Customized Unspecified	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections	41.77 events per 1000 participant-years Interval 36.09 to 48.34	22.28 events per 1000 participant-years Interval 18.57 to 26.73

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis	0.46 events per 1000 participant-years Interval 0.12 to 1.86	0.38 events per 1000 participant-years Interval 0.1 to 1.54

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) Non-AIDS defining Malignancies	9.98 events per 1000 participant-years Interval 7.4 to 13.45	10.56 events per 1000 participant-years Interval 8.11 to 13.76
Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) All Malignancies	13.69 events per 1000 participant-years Interval 10.61 to 17.67	12.87 events per 1000 participant-years Interval 10.13 to 16.35
Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) AIDS defining Malignancies	3.71 events per 1000 participant-years Interval 2.27 to 6.06	2.31 events per 1000 participant-years Interval 1.31 to 4.06

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Density Rate Per 1000 Participant-Years for Incidence of Liver Failure	2.55 events per 1000 participant-years Interval 1.41 to 4.61	2.50 events per 1000 participant-years Interval 1.45 to 4.3

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'	5.34 events per 1000 participant-years Interval 3.55 to 8.03	4.80 events per 1000 participant-years Interval 3.24 to 7.11

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'	7.43 events per 1000 participant-years Interval 5.25 to 10.5	8.26 events per 1000 participant-years Interval 6.13 to 11.14

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis	0.70 events per 1000 participant-years Interval 0.22 to 2.16	0.77 events per 1000 participant-years Interval 0.29 to 2.05

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause	1.16 events per 1000 participant-years Interval 0.48 to 2.79	0.77 events per 1000 participant-years Interval 0.29 to 2.05

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause	18.33 events per 1000 participant-years Interval 14.7 to 22.86	14.41 events per 1000 participant-years Interval 11.49 to 18.07

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections	28.70 events per 1000 participant-years Interval 23.98 to 34.34	22.36 events per 1000 participant-years Interval 18.56 to 26.94

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) All Malignancies	13.54 events per 1000 participant-years Interval 10.44 to 17.56	12.49 events per 1000 participant-years Interval 9.72 to 16.05
Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) AIDS defining Malignancies	3.31 events per 1000 participant-years Interval 1.95 to 5.62	2.31 events per 1000 participant-years Interval 1.29 to 4.13
Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies) Non-AIDS defining Malignancies	9.86 events per 1000 participant-years Interval 7.27 to 13.37	9.87 events per 1000 participant-years Interval 7.44 to 13.09

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'	3.37 events per 1000 participant-years Interval 2.06 to 5.52	2.08 events per 1000 participant-years Interval 1.21 to 3.56

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'	5.99 events per 1000 participant-years Interval 4.13 to 8.68	5.65 events per 1000 participant-years Interval 3.97 to 8.05

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause	15.64 events per 1000 participant-years Interval 12.3 to 19.89	14.39 events per 1000 participant-years Interval 11.41 to 18.16

PRIMARY outcome

Timeframe: Up to 5 years following enrollment

Population: Safety analysis set included all participants who were enrolled in the study.

All-cause death was defined as the death due to any cause during the course of study.

Outcome measures

Measure	Maraviroc Unexposed n=1130 Participants HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Exposed n=1316 Participants Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Percentage of Participants With All-Cause Mortality	7.0 Percentage of participants	5.7 Percentage of participants

Adverse Events

Maraviroc Exposed

Serious events: 435 serious events

Other events: 111 other events

Deaths: 75 deaths

Maraviroc Unexposed

Serious events: 352 serious events

Other events: 34 other events

Deaths: 79 deaths

Serious adverse events

Measure	Maraviroc Exposed n=1316 participants at risk Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Unexposed n=1130 participants at risk HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Blood and lymphatic system disorders Anaemia	0.84% 11/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	1.2% 14/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Anaemia of chronic disease	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Eosinophilia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Febrile neutropenia	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Haemolysis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Haemolytic anaemia	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Iron deficiency anaemia	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Leukopenia	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Methaemoglobinaemia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Neutropenia	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Pancytopenia	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Splenomegaly	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Thrombocytopenia	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Acute coronary syndrome	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Acute myocardial infarction	0.53% 7/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Angina pectoris	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Angina unstable	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Arrhythmia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Arteriosclerosis coronary artery	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Atrial fibrillation	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Bradycardia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Cardiac arrest	0.38% 5/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Cardiac failure	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Cardiac failure congestive	0.38% 5/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.97% 11/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Cardiac valve disease	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Cardio-respiratory arrest	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Cardiogenic shock	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Cardiomyopathy	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Coronary artery disease	0.46% 6/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Coronary artery stenosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Left ventricular dysfunction	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Left ventricular failure	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Myocardial infarction	1.2% 16/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	1.1% 12/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Myocardial ischaemia	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Myocarditis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Palpitations	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Pericarditis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Tachycardia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Cardiac disorders Torsade de pointes	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Congenital, familial and genetic disorders Fanconi syndrome	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Congenital, familial and genetic disorders Sickle cell disease	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Ear and labyrinth disorders Deafness bilateral	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Ear and labyrinth disorders Vertigo	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Ear and labyrinth disorders Vertigo positional	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Endocrine disorders Adrenal insufficiency	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Endocrine disorders Adrenal mass	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Endocrine disorders Autoimmune hypothyroidism	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Endocrine disorders Hypothyroidism	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Eye disorders Cataract	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Eye disorders Central vision loss	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Eye disorders Iridocyclitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Eye disorders Orbital cyst	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Eye disorders Pupils unequal	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Eye disorders Uveitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Eye disorders Vision blurred	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Abdominal distension	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Abdominal hernia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Abdominal pain	0.61% 8/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.97% 11/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Abdominal pain lower	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Abdominal wall haematoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Anal fissure	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Anal fistula	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Anal skin tags	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Anogenital dysplasia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Anorectal disorder	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Ascites	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Barrett's oesophagus	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Colitis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Constipation	0.38% 5/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Crohn's disease	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Diarrhoea	0.76% 10/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	1.2% 13/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Diverticulum	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Duodenitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Dyspepsia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Dysphagia	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Faeces discoloured	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Gastritis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Gastrointestinal disorder	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Haematemesis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Haematochezia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Haemorrhoids	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Haemorrhoids thrombosed	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Ileus	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Inguinal hernia	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Intestinal ischaemia	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Intestinal mass	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Intestinal obstruction	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Intestinal perforation	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Intussusception	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Large intestine perforation	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Melaena	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Nausea	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Odynophagia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Oesophageal haemorrhage	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Oesophageal rupture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Oesophageal stenosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Oesophageal ulcer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Oesophagitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Oral pain	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Pancreatic pseudocyst	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Pancreatitis	0.46% 6/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Pancreatitis acute	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Pancreatitis chronic	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Proctalgia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Proctitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Proctitis ulcerative	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Rectal perforation	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Rectal prolapse	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Small intestinal obstruction	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Umbilical hernia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Varices oesophageal	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Vomiting	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Asthenia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Chest pain	1.2% 16/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	1.3% 15/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Chills	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Death	0.76% 10/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Dysplasia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Fatigue	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Gait disturbance	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders General physical health deterioration	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Generalised oedema	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Hypothermia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Malaise	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Mucosal inflammation	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Multi-organ disorder	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Multiple organ dysfunction syndrome	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Oedema peripheral	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Pain	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Physical deconditioning	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Pyrexia	0.61% 8/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.97% 11/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Sudden cardiac death	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Sudden death	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Systemic inflammatory response syndrome	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Treatment noncompliance	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Ulcer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Acute hepatic failure	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Bile duct stone	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Biliary dilatation	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Cholecystitis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Cholelithiasis	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Hepatic cirrhosis	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Hepatic failure	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Hepatitis alcoholic	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Hepatitis toxic	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Hepatorenal syndrome	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Hepatobiliary disorders Jaundice	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Immune system disorders Drug hypersensitivity	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Immune system disorders Hypersensitivity	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Immune system disorders Jarisch-Herxheimer reaction	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations AIDS related complication	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations AIDS retinopathy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Abdominal abscess	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Abdominal sepsis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Abscess	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Abscess limb	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Acquired immunodeficiency syndrome	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Acute hepatitis C	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Acute sinusitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Amoebiasis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Amoebic dysentery	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Anal abscess	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Anorectal cellulitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Appendicitis	0.53% 7/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Arthritis bacterial	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Aspergillus infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Atypical mycobacterial infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Bacteraemia	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Bacterial diarrhoea	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Bacterial infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Brain abscess	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Breast abscess	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Bronchiolitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Bronchitis	0.76% 10/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Bronchitis viral	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Burkholderia cepacia complex sepsis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations CNS ventriculitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Campylobacter gastroenteritis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Campylobacter infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Candida infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cellulitis	0.91% 12/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	1.6% 18/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cellulitis staphylococcal	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cerebral toxoplasmosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Clostridium difficile colitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Clostridium difficile infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Corneal abscess	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cryptococcal fungaemia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cryptococcosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cryptosporidiosis infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cytomegalovirus chorioretinitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cytomegalovirus colitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cytomegalovirus infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Cytomegalovirus viraemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Device related infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Device related sepsis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Diabetic foot infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Diverticulitis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Empyema	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Encephalitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations End stage AIDS	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Endocarditis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Enterococcal sepsis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Epididymitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Erysipelas	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Escherichia bacteraemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Escherichia urinary tract infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations External ear cellulitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Eye infection syphilitic	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Folliculitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Fungal infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Fungal oesophagitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Furuncle	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Gangrene	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Gastroenteritis	0.53% 7/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.97% 11/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Gastroenteritis bacterial	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Gastroenteritis clostridial	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Gastroenteritis cryptosporidial	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Gastroenteritis salmonella	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Gastroenteritis viral	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Genital herpes	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Genital herpes simplex	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Giardiasis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Gonorrhoea	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations HIV enteropathy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations HIV infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations HIV wasting syndrome	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations HIV-associated neurocognitive disorder	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Helicobacter gastritis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Helicobacter infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Hepatitis B reactivation	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Hepatitis C	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Herpes pharyngitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Herpes simplex	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Herpes virus infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Herpes zoster	0.38% 5/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Herpes zoster disseminated	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Histoplasmosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Infectious colitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Infective exacerbation of bronchiectasis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Influenza	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Intervertebral discitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Joint abscess	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Klebsiella sepsis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Latent syphilis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Lower respiratory tract infection	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Lung infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Meningitis	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Meningitis aseptic	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Meningitis cryptococcal	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Meningitis streptococcal	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Meningitis tuberculous	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Microsporidia infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Mycobacterial infection	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Mycobacterium abscessus infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Mycobacterium avium complex infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Mycobacterium fortuitum infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Neurosyphilis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Neutropenic sepsis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Oesophageal candidiasis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.71% 8/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Oral candidiasis	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Oral hairy leukoplakia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Oral herpes	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Orchitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Osteomyelitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Osteomyelitis chronic	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Otitis externa	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Otitis media	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Parvovirus infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Perirectal abscess	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Peritonitis	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Peritonitis bacterial	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pharyngitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pilonidal cyst	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumococcal sepsis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumocystis jirovecii pneumonia	0.68% 9/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	1.2% 13/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumonia	3.9% 51/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	4.8% 54/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumonia bacterial	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumonia influenzal	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumonia legionella	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumonia necrotising	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumonia pneumococcal	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumonia pseudomonal	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumonia staphylococcal	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pneumonia streptococcal	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Post procedural infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Postoperative wound infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Progressive multifocal leukoencephalopathy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pyelonephritis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Pyelonephritis acute	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Rectal abscess	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Respiratory tract infection	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Salmonella sepsis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Secondary syphilis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Sepsis	0.84% 11/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.97% 11/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Sepsis syndrome	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Septic embolus	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Septic shock	0.38% 5/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Shigella infection	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Sinusitis	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Sinusitis bacterial	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Sinusitis fungal	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Staphylococcal abscess	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Staphylococcal bacteraemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Staphylococcal infection	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Staphylococcal skin infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Streptococcal bacteraemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Subcutaneous abscess	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Superinfection bacterial	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Syphilis	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Syphilis anal	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Tonsillitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Tooth abscess	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Toxoplasmosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Trichomoniasis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Tuberculosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Upper respiratory tract infection	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Urinary tract infection	0.76% 10/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.71% 8/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Urinary tract infection pseudomonal	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Urosepsis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Vaginal infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Vascular device infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Viral infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Vulval abscess	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Accident	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Alcohol poisoning	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Breast injury	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Chest injury	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Clavicle fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Concussion	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Craniocerebral injury	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Facial bones fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Fall	0.46% 6/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Femoral neck fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Femur fracture	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Foreign body in respiratory tract	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Fractured sacrum	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Gastrointestinal stoma necrosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Hand fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Head injury	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Hip fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Humerus fracture	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Intentional overdose	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Jaw fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Limb injury	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Lower limb fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Multiple injuries	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Overdose	0.53% 7/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Pubis fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Radial nerve injury	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Rib fracture	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Road traffic accident	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Spinal fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Splenic injury	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Subdural haematoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Tibia fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Toxicity to various agents	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Traumatic liver injury	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Vascular graft thrombosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Wound	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Injury, poisoning and procedural complications Wrist fracture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Atypical mycobacterium test positive	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Biopsy lymph gland	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Blood creatine phosphokinase increased	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Blood potassium decreased	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Body temperature increased	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Culture stool positive	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Drug clearance increased	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Electrocardiogram repolarisation abnormality	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations HIV test positive	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Haemophilus test positive	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Hepatic enzyme increased	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Liver function test abnormal	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Liver function test increased	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Staphylococcus test	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Staphylococcus test positive	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Transaminases increased	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Investigations Weight decreased	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Alcoholic ketoacidosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Cachexia	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Dehydration	0.38% 5/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.62% 7/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Diabetes mellitus	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Electrolyte depletion	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Failure to thrive	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Fluid overload	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Folate deficiency	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Gout	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Haemochromatosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hypercalcaemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hyperkalaemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hypocalcaemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hyponatraemia	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Hypovolaemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Lactic acidosis	0.38% 5/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Malnutrition	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Metabolism and nutrition disorders Vitamin D deficiency	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Arthropathy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Back pain	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Costochondritis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Diastasis recti abdominis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Fistula	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Myalgia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Myositis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Neck pain	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer stage 0	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal squamous cell carcinoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large cell lymphoma T- and null-cell types	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma recurrent	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous histiocytoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal lymphoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.46% 6/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative disorder	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage II	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ocular neoplasm	100.0% 1/1 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian germ cell teratoma benign	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma recurrent	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmablastic lymphoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal cancer	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Alcoholic seizure	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Amputation stump pain	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Balance disorder	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Cerebellar infarction	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Cerebral haemorrhage	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Cerebral infarction	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Cerebral ischaemia	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Cerebrovascular accident	0.53% 7/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Clonic convulsion	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Cranial nerve palsies multiple	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Dementia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Depressed level of consciousness	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Diabetic hyperglycaemic coma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Diabetic neuropathy	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Dizziness	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Dysarthria	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Embolic stroke	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Encephalitis post varicella	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Encephalopathy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Epilepsy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Facial paralysis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Generalised tonic-clonic seizure	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Haemorrhage intracranial	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Haemorrhagic stroke	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Headache	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Hemiparesis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Hepatic encephalopathy	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Hypoaesthesia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Intracranial aneurysm	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Intracranial pressure increased	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Ischaemic stroke	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Lacunar stroke	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Lethargy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Lumbar radiculopathy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Mental impairment	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Metabolic encephalopathy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Migraine	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Motor dysfunction	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Myoclonus	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Nervous system disorder	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Neuropathy peripheral	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Parkinson's disease	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Polyneuropathy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Radiculopathy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Seizure	0.61% 8/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Somnolence	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Subarachnoid haemorrhage	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Syncope	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Transient ischaemic attack	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Unresponsive to stimuli	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous complete	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Product Issues Device dislocation	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Adjustment disorder	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Affective disorder	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Aggression	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Alcohol withdrawal syndrome	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Alcoholism	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Bipolar I disorder	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Bipolar disorder	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Borderline personality disorder	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Completed suicide	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Confusional state	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Delirium	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Depression	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Depression suicidal	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Drug abuse	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Homicidal ideation	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Major depression	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Mania	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Mental status changes	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.71% 8/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Organic brain syndrome	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Psychotic disorder	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Schizoaffective disorder	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Schizophrenia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Substance abuse	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Substance-induced psychotic disorder	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Suicidal ideation	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Psychiatric disorders Suicide attempt	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Acute kidney injury	0.61% 8/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	1.6% 18/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Calculus urinary	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Chronic kidney disease	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders End stage renal disease	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Glomerulonephritis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Hydronephrosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Nephrolithiasis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Nephropathy	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Proteinuria	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Renal colic	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Renal failure	0.76% 10/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Renal haematoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Renal injury	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Renal tubular necrosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Renal vein thrombosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Ureteric stenosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Renal and urinary disorders Urinary incontinence	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Breast enlargement	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Cervical dysplasia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Fallopian tube obstruction	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Menorrhagia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Ovarian vein thrombosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Painful erection	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Pelvic adhesions	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Perineal rash	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Prostatomegaly	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Testicular swelling	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Uterine polyp	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Reproductive system and breast disorders Vaginal prolapse	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Asthma	0.38% 5/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.62% 7/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Cough	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.46% 6/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Emphysema	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.35% 4/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.53% 7/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary eosinophilia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.71% 8/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Dermal cyst	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Lipodystrophy acquired	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Neurodermatitis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Psoriasis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Rash	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Skin ulcer	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Abdominal hernia repair	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Abscess drainage	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Arterial stent insertion	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Arteriovenous fistula operation	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Cardiac resynchronisation therapy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Cataract operation	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Colostomy	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Gastric banding reversal	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Hip surgery	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Hysterectomy	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Immune tolerance induction	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Inguinal hernia repair	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Knee arthroplasty	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Leg amputation	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Medical device removal	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Renal transplant	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Surgical and medical procedures Valvuloplasty cardiac	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Aortic aneurysm	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Aortic aneurysm rupture	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Aortic arteriosclerosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Bleeding varicose vein	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Circulatory collapse	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Deep vein thrombosis	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Haematoma	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Hypertension	0.30% 4/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Hypertensive crisis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Hypotension	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.62% 7/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Hypovolaemic shock	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Iliac artery occlusion	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Jugular vein thrombosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Lymphoedema	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Orthostatic hypotension	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Peripheral arterial occlusive disease	0.23% 3/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.18% 2/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Peripheral artery occlusion	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Peripheral artery stenosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Peripheral ischaemia	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Peripheral vascular disorder	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Subclavian artery thrombosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Subclavian vein thrombosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Thrombophlebitis	0.15% 2/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Thrombosis	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Vascular stenosis	0.00% 0/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.09% 1/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Vascular disorders Vasospasm	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.08% 1/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.

Other adverse events

Measure	Maraviroc Exposed n=1316 participants at risk Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	Maraviroc Unexposed n=1130 participants at risk HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
Gastrointestinal disorders Diarrhoea	2.4% 32/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	1.2% 14/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Gastrointestinal disorders Nausea	1.4% 18/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
General disorders Fatigue	1.1% 15/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Bronchitis	1.4% 18/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Infections and infestations Nasopharyngitis	1.2% 16/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.00% 0/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 18/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.27% 3/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Nervous system disorders Headache	1.2% 16/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.53% 6/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.
Skin and subcutaneous tissue disorders Rash	1.3% 17/1316 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.	0.44% 5/1130 • Up to 5 years following enrollment Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

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

Restriction type: OTHER