Trial Outcomes & Findings for Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS (NCT NCT02525939)

Participant milestones
Measure	Dalcetrapib Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets	Placebo Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets
Overall Study STARTED	3071	3076
Overall Study Took Study Medication	3064	3064
Overall Study COMPLETED	2840	2833
Overall Study NOT COMPLETED	231	243

Reasons for withdrawal
Measure	Dalcetrapib Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets	Placebo Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets
Overall Study Lost to Follow-up	27	24
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	24	39
Overall Study Death	180	179

Baseline characteristics by cohort
Measure	Dalcetrapib n=3071 Participants Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets	Placebo n=3076 Participants Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets	Total n=6147 Participants Total of all reporting groups
Age, Continuous	62.19 years STANDARD_DEVIATION 9.16 • n=3071 Participants	62.34 years STANDARD_DEVIATION 9.25 • n=3076 Participants	62.26 years STANDARD_DEVIATION 9.21 • n=6147 Participants
Sex: Female, Male Female	723 Participants n=3071 Participants	672 Participants n=3076 Participants	1395 Participants n=6147 Participants
Sex: Female, Male Male	2348 Participants n=3071 Participants	2404 Participants n=3076 Participants	4752 Participants n=6147 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	469 Participants n=3071 Participants	469 Participants n=3076 Participants	938 Participants n=6147 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2551 Participants n=3071 Participants	2550 Participants n=3076 Participants	5101 Participants n=6147 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	51 Participants n=3071 Participants	57 Participants n=3076 Participants	108 Participants n=6147 Participants
Race (NIH/OMB) American Indian or Alaska Native	11 Participants n=3071 Participants	12 Participants n=3076 Participants	23 Participants n=6147 Participants
Race (NIH/OMB) Asian	58 Participants n=3071 Participants	59 Participants n=3076 Participants	117 Participants n=6147 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	15 Participants n=3071 Participants	15 Participants n=3076 Participants	30 Participants n=6147 Participants
Race (NIH/OMB) Black or African American	130 Participants n=3071 Participants	123 Participants n=3076 Participants	253 Participants n=6147 Participants
Race (NIH/OMB) White	2771 Participants n=3071 Participants	2798 Participants n=3076 Participants	5569 Participants n=6147 Participants
Race (NIH/OMB) More than one race	85 Participants n=3071 Participants	68 Participants n=3076 Participants	153 Participants n=6147 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=3071 Participants	1 Participants n=3076 Participants	2 Participants n=6147 Participants
Region of Enrollment United Arab Emirates	9 participants n=3071 Participants	7 participants n=3076 Participants	16 participants n=6147 Participants
Region of Enrollment Argentina	74 participants n=3071 Participants	74 participants n=3076 Participants	148 participants n=6147 Participants
Region of Enrollment Australia	100 participants n=3071 Participants	102 participants n=3076 Participants	202 participants n=6147 Participants
Region of Enrollment Austria	23 participants n=3071 Participants	27 participants n=3076 Participants	50 participants n=6147 Participants
Region of Enrollment Belgium	22 participants n=3071 Participants	17 participants n=3076 Participants	39 participants n=6147 Participants
Region of Enrollment Bulgaria	201 participants n=3071 Participants	185 participants n=3076 Participants	386 participants n=6147 Participants
Region of Enrollment Brazil	218 participants n=3071 Participants	213 participants n=3076 Participants	431 participants n=6147 Participants
Region of Enrollment Canada	209 participants n=3071 Participants	228 participants n=3076 Participants	437 participants n=6147 Participants
Region of Enrollment Switzerland	21 participants n=3071 Participants	15 participants n=3076 Participants	36 participants n=6147 Participants
Region of Enrollment Chile	44 participants n=3071 Participants	50 participants n=3076 Participants	94 participants n=6147 Participants
Region of Enrollment Czechia	73 participants n=3071 Participants	78 participants n=3076 Participants	151 participants n=6147 Participants
Region of Enrollment Germany	28 participants n=3071 Participants	41 participants n=3076 Participants	69 participants n=6147 Participants
Region of Enrollment Denmark	66 participants n=3071 Participants	71 participants n=3076 Participants	137 participants n=6147 Participants
Region of Enrollment Spain	84 participants n=3071 Participants	104 participants n=3076 Participants	188 participants n=6147 Participants
Region of Enrollment Finland	9 participants n=3071 Participants	11 participants n=3076 Participants	20 participants n=6147 Participants
Region of Enrollment France	49 participants n=3071 Participants	50 participants n=3076 Participants	99 participants n=6147 Participants
Region of Enrollment United Kingdom	200 participants n=3071 Participants	183 participants n=3076 Participants	383 participants n=6147 Participants
Region of Enrollment Hungary	82 participants n=3071 Participants	101 participants n=3076 Participants	183 participants n=6147 Participants
Region of Enrollment Israel	198 participants n=3071 Participants	175 participants n=3076 Participants	373 participants n=6147 Participants
Region of Enrollment Italy	69 participants n=3071 Participants	54 participants n=3076 Participants	123 participants n=6147 Participants
Region of Enrollment Netherlands	129 participants n=3071 Participants	147 participants n=3076 Participants	276 participants n=6147 Participants
Region of Enrollment New Zealand	75 participants n=3071 Participants	74 participants n=3076 Participants	149 participants n=6147 Participants
Region of Enrollment Poland	166 participants n=3071 Participants	169 participants n=3076 Participants	335 participants n=6147 Participants
Region of Enrollment Puerto Rico	10 participants n=3071 Participants	4 participants n=3076 Participants	14 participants n=6147 Participants
Region of Enrollment Romania	92 participants n=3071 Participants	87 participants n=3076 Participants	179 participants n=6147 Participants
Region of Enrollment Russia	215 participants n=3071 Participants	240 participants n=3076 Participants	455 participants n=6147 Participants
Region of Enrollment Slovakia	21 participants n=3071 Participants	27 participants n=3076 Participants	48 participants n=6147 Participants
Region of Enrollment Sweden	35 participants n=3071 Participants	30 participants n=3076 Participants	65 participants n=6147 Participants
Region of Enrollment Turkey	31 participants n=3071 Participants	26 participants n=3076 Participants	57 participants n=6147 Participants
Region of Enrollment United States	370 participants n=3071 Participants	358 participants n=3076 Participants	728 participants n=6147 Participants
Region of Enrollment South Africa	121 participants n=3071 Participants	101 participants n=3076 Participants	222 participants n=6147 Participants
Region of Enrollment Portugal	27 participants n=3071 Participants	27 participants n=3076 Participants	54 participants n=6147 Participants
Reproductive status if female Childbearing potential with double contraceptive protection	24 Participants n=723 Participants • Only female subjects are considered in this baseline measure.	24 Participants n=672 Participants • Only female subjects are considered in this baseline measure.	48 Participants n=1395 Participants • Only female subjects are considered in this baseline measure.
Reproductive status if female Childbearing potential without double contraceptive potential	1 Participants n=723 Participants • Only female subjects are considered in this baseline measure.	1 Participants n=672 Participants • Only female subjects are considered in this baseline measure.	2 Participants n=1395 Participants • Only female subjects are considered in this baseline measure.
Reproductive status if female Postmenopausal	602 Participants n=723 Participants • Only female subjects are considered in this baseline measure.	584 Participants n=672 Participants • Only female subjects are considered in this baseline measure.	1186 Participants n=1395 Participants • Only female subjects are considered in this baseline measure.
Reproductive status if female Surgically sterilized	92 Participants n=723 Participants • Only female subjects are considered in this baseline measure.	60 Participants n=672 Participants • Only female subjects are considered in this baseline measure.	152 Participants n=1395 Participants • Only female subjects are considered in this baseline measure.
Reproductive status if female Other	4 Participants n=723 Participants • Only female subjects are considered in this baseline measure.	3 Participants n=672 Participants • Only female subjects are considered in this baseline measure.	7 Participants n=1395 Participants • Only female subjects are considered in this baseline measure.
Acute Coronary Syndrome (ACS) Index Event Details: Time since ACS index event	53.82 days STANDARD_DEVIATION 18.09 • n=3071 Participants	54.01 days STANDARD_DEVIATION 18.31 • n=3076 Participants	53.91 days STANDARD_DEVIATION 18.20 • n=6147 Participants
Acute Coronary Syndrome (ACS) Index Event Details: Hospitalization duration	6.06 days STANDARD_DEVIATION 4.33 • n=3071 Participants	6.22 days STANDARD_DEVIATION 5.03 • n=3076 Participants	6.14 days STANDARD_DEVIATION 4.69 • n=6147 Participants
Acute Coronary Syndrome (ACS) Index Event Diagnosis Spontaneous Myocardial Infarction (MI)	2756 Participants n=3071 Participants	2742 Participants n=3076 Participants	5498 Participants n=6147 Participants
Acute Coronary Syndrome (ACS) Index Event Diagnosis Procedure-related Myocardial Infarction (MI) after Percutaneous Coronary Intervention (PCI)	20 Participants n=3071 Participants	28 Participants n=3076 Participants	48 Participants n=6147 Participants
Acute Coronary Syndrome (ACS) Index Event Diagnosis Hospitalization for Acute Coronary Syndrome (Electrocardiogram abnormalities without biomarkers)	295 Participants n=3071 Participants	306 Participants n=3076 Participants	601 Participants n=6147 Participants
Acute Coronary Syndrome (ACS) Index Event Diagnosis: Second ACS event since qualifying index event No	2998 Participants n=3071 Participants	3008 Participants n=3076 Participants	6006 Participants n=6147 Participants
Acute Coronary Syndrome (ACS) Index Event Diagnosis: Second ACS event since qualifying index event Yes	73 Participants n=3071 Participants	68 Participants n=3076 Participants	141 Participants n=6147 Participants

Outcome measures
Measure	Placebo n=3076 Participants Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets	Dalcetrapib n=3071 Participants Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
Composite of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, and Non-Fatal Stroke	327 Participants	292 Participants

Outcome measures
Measure	Placebo n=3076 Participants Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets	Dalcetrapib n=3071 Participants Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke, Hospitalization for ACS (With Electrocardiogram Abnormalities) or Unanticipated Coronary Revascularization	471 Participants	471 Participants

Outcome measures
Measure	Placebo n=3076 Participants Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets	Dalcetrapib n=3071 Participants Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
Composite Endpoint of Cardiovascular Death, Resuscitated Cardiac Arrest, Non-Fatal Myocardial Infarction, Non-Fatal Stroke or Hospitalization for New or Worsening Heart Failure	346 Participants	321 Participants

Blood and lymphatic system disorders

Anaemia

0.68%

21/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.62%

19/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Febrile Neutropenia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Hemorrhagic anaemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Hypchromic anaemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Iron deficiency anaemia

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Leukocytosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Leukopenia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Lymphadenopathy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Microcytic anaemia

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Neutropenia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Non-Hodgkin's lymphoma recurrent

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Pancytopenia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Splenic haematoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Splenic infarction

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Splenic vein thrombosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Blood and lymphatic system disorders

Thrombocytopenia

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Acute Coronary Syndrome

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Adams-Stokes Syndrome

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Angina pectoris

1.6%

50/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

1.7%

52/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Angina unstable

0.75%

23/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.62%

19/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Aortic valve disease

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Aortic valve incompetence

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Aortic valve stenosis

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Arrhythmia

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Arteriosclerosis coronary artery

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Arteriospasm coronary

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Atrial fibrillation

1.2%

36/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

1.0%

31/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Atrial flutter

0.20%

6/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Atrial tachycardia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Atrioventricular block

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Atrioventricular block complete

0.20%

6/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Atrioventricular block second degree

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Bradycardia

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiac aneurysm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiac arrest

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiac failure

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiac failure acute

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiac failure chronic

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiac tamponade

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiac valve disease

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiac ventricular thrombosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardio-respiratory arrest

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiogenic shock

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiomyopathy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiopulmonary failure

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cardiovascular insufficiency

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Carditis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Chest pain

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Cor pulmonale

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Coronary artery disease

0.75%

23/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.98%

30/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Coronary artery dissection

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Coronary artery occlusion

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Coronary artery perforation

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Coronary artery stenosis

0.23%

7/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Ischaemic cardiomyopathy

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Left ventricular dysfunction

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Left ventricular failure

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Long QT syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Mitral valve incompetence

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Myocardial haemorrhage

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Myocardia ischaemia

0.39%

12/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.39%

12/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Myocarditis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Palpitations

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Pericardial effusion

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Pericarditis

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Right ventricular failure

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Sinus arrest

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Sinus bradycardia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Sinus node dysfunction

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Sinus tachycardia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Supraventricular extrasystoles

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Supraventricular tachycardia

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Systolic dysfunction

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Tachycardia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Tricuspid valve incompetence

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Ventricular arrhythmia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Ventricular extrasystoles

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Ventricular fibrillation

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Cardiac disorders

Ventricular tachycardia

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.26%

8/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Congenital, familial and genetic disorders

Atrial septal defect

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Congenital, familial and genetic disorders

Bicuspid aortic valve

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Congenital, familial and genetic disorders

Hydrocele

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Ear and labyrinth disorders

Ear canal stenosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Ear and labyrinth disorders

Meniere's disease

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Ear and labyrinth disorders

Tinnitus

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Ear and labyrinth disorders

Vertigo

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Ear and labyrinth disorders

Vertigo positional

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Endocrine disorders

Adrenal insufficiency

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Endocrine disorders

Autoimmune thyroiditis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Endocrine disorders

Cushing's syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Endocrine disorders

Hyperparathyroidism primary

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Endocrine disorders

Thyroid mass

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Endocrine disorders

Toxic goitre

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Eye disorders

Blindness transient

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Eye disorders

Cataract

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Eye disorders

Lens dislocation

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Eye disorders

Optic nerve disorder

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Eye disorders

Retinal detachment

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Eye disorders

Retinal tear

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Eye disorders

Retinopathy of prematurity

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Eye disorders

Visual acuity reduced

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Eye disorders

Vitreous haemorrhage

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Abdominal adhesions

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Abdominal discomfort

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Abdominal hernia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Abdominal pain

0.20%

6/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Abdominal pain lower

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Abdominal pain upper

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Adenocarcinoma pancreas

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Anal fissure

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Aphthous ulcer

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Ascites

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Auriculotemporal syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Barrett's oesophagus

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Coeliac artery stenosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Colitis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Colitis ischaemic

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Colitis ulcerative

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Constipation

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Diarrhoea

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Diverticular perforation

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Diverticulum intestinal

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Diverticulum intestinal haemorrhagic

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Duodenal ulcer

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Duodenal ulcer haemorrhage

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Duodenitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Dyspepsia

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Dysphagia

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Enteritis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Faecaloma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Functional gastrointestinal disorder

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastric haemorrhage

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastric ulcer

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastric ulcer haemorrhage

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastric ulcer perforation

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastritis

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastritis erosive

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastritis haemorrhagic

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastrointestinal angiodysplasia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastrointestinal haemorrhage

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastrointestinal necrosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gastrooesophageal reflux disease

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Gingival recession

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Haematemesis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Haematochezia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Haemorrhagic erosive gastritis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Haemorrhoidal haemorrhage

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Haemorrhoids

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Hernial eventration

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Hiatus hernia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Ileus

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Ileus paralytic

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Impaired gastric emptying

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Inflammatory bowel disease

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Inguinal hernia

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Inguinal hernia strangulated

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Intestinal haemorrhage

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Intestinal ischaemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Intestinal obstruction

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Intestinal perforation

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Large intestinal polyp

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Lower gastrointestinal haemorrhage

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Mallory-Weiss syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Melaena

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Mesenteric panniculitis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Oesophageal dysplasia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Pancreatitis

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Pancreatitis acute

0.46%

14/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.20%

6/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Pancreatitis chronic

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Peptic ulcer

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Portal venous gas

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Proctalgia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Rectal haemorrhage

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Retroperitoneal haematoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Small intestinal obstruction

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Small intestinal ulcer haemorrhage

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Subileus

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Umbilical hernia

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Upper gastrointestinal haemorrhage

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Volvulus

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Gastrointestinal disorders

Vomiting

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Asthenia

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Cardiac death

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Chest discomfort

0.23%

7/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Chest pain

2.6%

79/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

2.6%

81/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Death of unknown cause

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.55%

17/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Drowning

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Drug intolerance

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Exercise tolerance decreased

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Fatigue

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

General physical health deterioration

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Generalized oedema

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Impaired self-care

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Multiple organ dysfunction syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Nodule

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Non-cardiac chest pain

0.91%

28/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

1.3%

41/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Oedema

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Oedema peripheral

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Pacemaker generated arrhythmia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Polyp

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Pyrexia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Sudden cardiac death

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.26%

8/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Sudden death

0.46%

14/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.52%

16/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Systemic inflammatory response syndrome

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Vascular stent restenosis

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

General disorders

Vascular stent stenosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Acute hepatic failure

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Bile duct obstruction

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Bile duct stenosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Bile duct stone

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Biliary colic

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Cholangitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Cholangitis acute

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Cholecystitis

0.33%

10/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.26%

8/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Cholecystitis acute

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.26%

8/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Cholecystitis chronic

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Cholelithiasis

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Drug-induced liver injury

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Hepatic cyst

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Hepatic function abnormal

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Hepatic lesion

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Hepatitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Hepatitis toxic

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Hepatocellular injury

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Jaundice

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Jaundice cholestatic

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Liver injury

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Hepatobiliary disorders

Non-alcoholic steatohepatitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Immune system disorders

Anaphylactic reaction

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Immune system disorders

Drug hypersensitivity

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Immune system disorders

Food allergy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Immune system disorders

Hypersensitivity

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Immune system disorders

Sarcoidosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Abdominal abscess

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Abscess limb

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Abscess of salivary gland

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Abscess oral

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Anal abscess

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Appendicitis

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Appendicitis perforated

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Arteriosclerotic gangrene

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Arthritis bacterial

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Bacteraemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Bacterial infection

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Biliary sepsis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Brain abscess

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Bronchitis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Cardiac valve vegetation

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Cellulitis

0.39%

12/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.39%

12/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Cellulitis staphylococcal

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Central nervous system infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Cholecystitis infective

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Clostridium difficile colitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Clostridium difficile infection

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Colonic abscess

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Corona virus infection

1.4%

43/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

1.5%

45/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Creutzfeldt-Jakob disease

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Cystitis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Device related infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Diabetic foot infection

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Diarrhoea infectious

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Diverticulitis

0.20%

6/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Ear infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Eczema infected

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Empyema

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Endocarditis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Endocarditis bacterial

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Epididymitis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Erysipelas

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Escherichia bacteraemia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Escherichia infection

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Escherichia pyelonephritis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Gangrene

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Gastric ulcer helicobacter

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Gastritis bacterial

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Gastroenteritis

0.33%

10/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.26%

8/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Gastroenteritis viral

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Gastrointestinal infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Haematoma infection

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Haemophilus bacteraemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Helicobacter infection

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Hepatitis C

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Herpes zoster

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Herpes zoster oticus

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Implant site infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Infected lymphocele

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Infectious colitis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Infective exacerbation of bronchiectasis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Infective exacerbation of chronic obstructive airways disease

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Influenza

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Klebsiella bacteraemia

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Klebsiella sepsis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Liver abscess

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Localized infection

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Lower respiratory tract infection

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Lung abscess

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Lung infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Neutropenic sepsis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Nosocomial infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Ophthalmic herpes simplex

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Orchitis

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Osteomyelitis

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pancreas infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Parainfluenzae virus infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Perirectal abscess

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Peritonitis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pneumonia

1.3%

41/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

1.3%

39/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pneumonia bacterial

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pneumonia escherichia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pneumonia legionella

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pneumonia necrotising

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pneumonia respiratory syncytial viral

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pneumonia staphylococcal

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pneumonia viral

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Postoperative wound infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pulmonary tuberculosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pyelonephritis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pyelonephritis acute

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Pyelonephritis chronic

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Respiratory syncytial viral infection

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Respiratory tract infection

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Respiratory tract infection bacterial

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Scrotal abscess

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Sepsis

0.62%

19/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.46%

14/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Septic shock

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.33%

10/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Serratia bacteraemia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Shunt infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Sinusitis

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Staphylococcal bacteraemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Streptococcal bacteraemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Tracheobronchitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Tuberculosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Upper respiratory tract infection

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Urinary tract infection

0.23%

7/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.55%

17/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Urinary tract infection bacterial

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Urosepsis

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Vestibular neuronitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Viral infection

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Infections and infestations

Wound infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Alcohol poisoning

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Anastomotic complication

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Anastomotic leak

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Ankle fracture

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Arterial bypass thrombosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Arterial injury

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Arterial restenosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Bile duct stenosis traumatic

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Cervical vertebral fracture

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Chest injury

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Clavicle fracture

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Comminuted fracture

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Concussion

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Contusion

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Coronary artery restenosis

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Costal cartilage fracture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Craniocerebral injury

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Electric shock

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Extradural haematoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Eye burns

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Fall

0.20%

6/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.36%

11/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Femoral neck fracture

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Femur fracture

0.20%

6/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Fibula fracture

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Foreign body

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Gastrointestinal stoma complication

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Haematuria traumatic

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Hand fracture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Head injury

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Hip fracture

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Humerus fracture

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Incisional hernia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Incomplete spinal fusion

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Injury

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Intentional overdose

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Joint dislocation

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Joint injury

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Ligament rupture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Ligament sprain

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Limb injury

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Lower limb fracture

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Lumbar vertebral fracture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Meniscus injury

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Multiple injuries

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Overdose

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Patella fracture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Pelvic fracture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Peripheral artery restenosis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Perirenal haematoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Post procedural bile leak

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Post procedural complication

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Pst procedural discomfort

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Post procedural haematoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Post procedural haemorrhage

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Postoperative respiratory failure

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Procedural haemorrhage

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Procedural nausea

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Procedural pain

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Radius fracture

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Respiratory fume inhalation disorder

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Rib fracture

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Road traffic accident

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Snake bite

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Soft tissue injury

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Spinal fracture

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Stab wound

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Sternal fracture

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Subarachnoid haemorrhage

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Subdural haematoma

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Subdural haemorrhage

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Tendon rupture

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Thoracic vertebral fracture

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Tibia fracture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Ulna fracture

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Upper limb fracture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Urinary retention postoperative

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Vascular graft stenosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Vascular graft thrombosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Vascular psudoaneurysm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Wound

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Wound dehiscence

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Wound haemorrhage

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Wound secretion

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Injury, poisoning and procedural complications

Wrist fracture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Angiogram

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Arteriogram coronary

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Biopsy prostate

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Blood creatinine increased

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Blood folate decreased

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Blood potassium increased

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Blood pressure increased

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Cardiac murmur

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Cardiac stress test abnormal

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Carotid bruit

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Catheterization cardiac

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Catheterisation cardiac abnormal

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Cystoscopy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Diagnostic procedure

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Ejection fraction decreased

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Electrocardiogram QT prolonged

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Fibrin D dimer increased

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Haemoglobin decreased

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Hepatic enzyme increased

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

International normalised ratio increased

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Liver function test abnormal

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Occult blood positive

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Pancreatic enzymes increased

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Sleep study

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Staphylococcus test positive

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Stress echocardiogram abnormal

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Troponin increased

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Utereroscopy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Investigations

Weight decreased

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Adult failure to thrive

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Decreased appetite

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Dehydration

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Diabetes mellitus

0.20%

6/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Diabetes mellitus inadequate control

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Diabetes with hyperosmolarity

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Diabetic ketoacidosis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Diabetic metabolic decompensation

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Electrolyte imbalance

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Failure to thrive

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Gout

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Hypercalcaemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Hyperglycaemia

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Hyperkalaemia

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Hyperosmolar hyperglycemic state

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Hypoglycaemia

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Hypokalaemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Hyponatraemia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Lactic acidosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Metabolic acidosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Obesity

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Metabolism and nutrition disorders

Type 2 diabetes mellitus

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Ankylosing spondylitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Arthralgia

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Arthritis

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Arthritis reactive

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Back pain

0.29%

9/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Cervical spinal stenosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Chondrocalcinosis pyrophosphate

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Facet joint syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Foot deformity

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Gouty arthritis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Intervertebral disc degeneration

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Intervertebral disc disorder

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.20%

6/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Joint effusion

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Knee impingement syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Limb deformity

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Lumbar spinal stenosis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Mobility decreased

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Muscle twitching

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Muscular weakness

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Musculoskeletal chest pain

0.29%

9/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Musculoskeletal pain

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Myalgia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Neck pain

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Osteoarthritis

0.88%

27/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.75%

23/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Osteolysis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Osteonecrosis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Osteoporosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Pain in extremity

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Pain in jaw

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Pathological fracture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Polymyalgia rheumatica

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Psoriatic arthropathy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Rhabdomyolysis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Rheumatoid arthritis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Rotator cuff syndrome

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Spinal column stenosis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Spinal disorder

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Spinal pain

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Spondylitis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Tendonitis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Musculoskeletal and connective tissue disorders

Vertebral osteophyte

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Abdominal neoplasm

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute leukaemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Acute myeloid leukaemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma of colon

0.20%

6/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Anal squamous cell carcinoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Atypical fibroxanthoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal cell carcinoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign lung neoplasm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of prostate

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Benign neoplasm of thyroid gland

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder cancer

0.29%

9/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder neoplasm

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bladder transitional cell carcinoma

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Brain neoplasm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.20%

6/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer metastatic

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Breast cancer stage II

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cancer pain

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Carcinoid tumour

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cervix carcinoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chest wall tumour

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cholesteatoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic lymphocytic leukaemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Chronic lymphocytic leukaemia stage 1

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon adenoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer metastatic

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon cancer stage IV

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colon neoplasm

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal cancer

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Diffuse large B-cell lymphoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Endometrial sarcoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Epstein-Barr virus associated lymphoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Extranodal marginal zone B-cell lymphoma (MALT type)

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric cancer

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Giant cell tumour of tendon sheath

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Glioblastoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Glioma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic cancer

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatic cancer recurrent

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hepatocellular carcinoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Hodgkin's disease

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intestina adenocarcinoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intraductal proliferative breast lesion

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Invasive ductal breast carcinoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal cancer

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Laryngeal papilloma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Leiomyoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lip and/or oral cavity cancer

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lipoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma metastatic

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma stage III

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung cancer metastatic

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung neoplasm malignant

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.20%

6/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lymphoma

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant melanoma in situ

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Malignant polyp

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Meningioma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to adrenals

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to bone

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to liver

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lung

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lymph nodes

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic carcinoma of the bladder

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic neoplasm

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastatic renal cell carcinoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myelodysplastic syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Myeloproliferative neoplasm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm malignant

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neoplasm prostate

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine carcinoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine carcinoma metastatic

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Neuroendocrine tumour

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-Hodgkin's lymphoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Non-small cell lung cancer metastatic

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal adenocarcinoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal carcinoma

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oesophageal neoplasm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Oropharyngeal neoplasm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ovarian epithelial cancer

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma

0.20%

6/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pancreatic carcinoma metastatic

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Parathyroid tumour benign

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Plasma cell myeloma

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Plasma cell myeloma recurrent

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Pleural neoplasm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Polycythaemia vera

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer

0.88%

27/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.33%

10/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer metastatic

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer recurrent

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Prostate cancer stage I

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal adenocarcinoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Rectal cancer

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cancer

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal cell carcinoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Renal neoplasm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small cell lung cancer metastatic

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Small intestine carcinoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of lung

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Thyroid cancer

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tongue neoplasm

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Transitional cell cancer of the renal pelvis and ureter

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Transitional cell carcinoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Tumour haemorrhage

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Ureteral neoplasm

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Uterine leiomyoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Balance disorder

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Burning sensation

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Carotid artery disease

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Carotid artery occlusion

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Carotid artery stenosis

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Carpal tunnel syndrome

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Cauda equina syndrome

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Cerebral artery stenosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Cerebral haematoma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Cerebral haemorrhage

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Cerebral ischaemia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Cerebrovascular accident

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Cervical radiculopathy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Cervicobrachial syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Cognitive disorder

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Coma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Dementia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Dementia Alzheimer's type

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Diabetic ketoacidotic hyperglycaemic coma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Disturbance in attention

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Dizziness

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Encephalopathy

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Epilepsy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Generalized tonic-clonic seizure

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Guillain-Barre syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Headache

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Hemiparesis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Hydrocephalus

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Hypoaesthesia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Hypoglycaemic coma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Hypoxic-ischaemic encephalopathy

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Loss of consciousness

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Lumbar radiculopathy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Lumbosacral radicuopathy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Memory impairment

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Metabolic encephalopathy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Migraine

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Monoparesis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Nervous system disorder

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Neuralgia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Parkinson's disease

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Polyneuropathy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Presyncope

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Radicular pain

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Sciatica

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Seizure

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Status epilepticus

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Syncope

0.91%

28/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.78%

24/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Transient ischemic attack

0.33%

10/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.20%

6/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Tremor

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Vascular dementia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Vertebral artery stenosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Nervous system disorders

Vertebrobasilar insufficiency

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Product Issues

Device dislocation

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Product Issues

Device material issue

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Alcohol abuse

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Alcohol withdrawal syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Alcoholism

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Anxiety

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Aphasia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Confusional state

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Conversion disorder

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Delirium

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Depression

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Hallucinations, mixed

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Mania

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Mental status changes

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Post-traumatic stress disorder

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Psychotic disorder

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Schizoaffective disorder

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Somatic symptom disorder

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Substance abuse

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Psychiatric disorders

Suicidal ideation

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Acute kidney injury

0.65%

20/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.59%

18/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Anuria

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Bladder dysplasia

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Calculus bladder

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Calculus urinary

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Chronic kidney disease

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Haematuria

0.29%

9/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.42%

13/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Haemorrhage urinary tract

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Hydronephrosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Micturition disorder

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Nephrolithiasis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Pelvi-ureteric obstruction

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Proteinuria

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Renal colic

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Renal failure

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Renal impairment

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Renal injury

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Renal pain

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Ureteric stenosis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Ureterolithiasis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Urethral haemorrhage

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Urethral stenosis

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Urinary incontinence

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Urinary retention

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.29%

9/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Renal and urinary disorders

Urinary tract infection

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Reproductive system and breast disorders

Benign prostatic hyperplasia

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.29%

9/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Reproductive system and breast disorders

Breast cyst

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Reproductive system and breast disorders

Breast disorder

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Reproductive system and breast disorders

Endometrial hyperplasia

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Reproductive system and breast disorders

Prostatitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Reproductive system and breast disorders

Prostatomegaly

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Reproductive system and breast disorders

Uterine polyp

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Reproductive system and breast disorders

Uterine prolapse

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Reproductive system and breast disorders

Vaginal prolapse

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Acute respiratory distress syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.20%

6/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Aspiration

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Asthma

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Bronchiectasis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Bronchitis chronic

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Bronchopneumopathy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Bronchospasm

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Bullous lung disease

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Chronic obstructive pulmonary disease

0.62%

19/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.49%

15/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Chronic respiratory failure

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Dyspnoea

0.26%

8/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.52%

16/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Dyspnoea exertional

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Epistaxis

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.26%

8/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Haemoptysis

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Haemothorax

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Hypoxia

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Laryngeal granuloma

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Lung disorder

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Lung infiltration

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Nasal obstruction

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Non-cardiogenic pulmonary oedema

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pleural effusion

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pleuritic pain

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pneumonitis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pneumothorax

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pneumothorax spontaneous

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pulmonary arterial hypertension

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pulmonary congestion

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pulmonary fibrosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pulmonary mass

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Pulmonary oedema

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Respiratory acidosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Respiratory failure

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.26%

8/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Sleep apnoea syndrome

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Respiratory, thoracic and mediastinal disorders

Vocal cord polyp

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Angioedema

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Decubitus ulcer

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Dermatitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Diabetic foot

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Ecchymosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Eczema

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Rash

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Skin disorder

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Skin lesion

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Skin mass

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Skin ulcer

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Swelling face

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Skin and subcutaneous tissue disorders

Xanthelasma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Social circumstances

Alcohol use

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Social circumstances

Sight disability

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Aneurysm repair

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Angioplasty

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Arthrodesis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Atherectomy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Blood pressure management

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Bone lesion excision

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Cardiac ablation

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Cardiac pacemaker insertion

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Cardiac pacemaker replacement

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Cardiac rehabilitation therapy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Cardiac resynchronisation therapy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Cataract operation

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Cholecystectomy

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Cholelithotomy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Colostomy closure

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Coronary angioplasty

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Coronary arterial stent insertion

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Coronary artery bypass

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Coronary revascularisation

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Finger amputation

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Gastrectomy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Heart transplant

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Hepatectomy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Hernia repair

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Hip arthroplasty

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Implantable defibrillator insertion

0.36%

11/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Insertion of ambulatory peritoneal catheter

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Keratoplasty

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Knee arthroplasty

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Left atrial appendage occlusion

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Limb amputation

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Lithotripsy

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Medical device change

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Ophthalmic fluid drainage

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Ossiculoplasty

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Percutaneous coronary intervention

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Rehabilitation therapy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Renal transpant

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Soft tissue flap operation

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Stem cell transplant

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Tooth extraction

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Tumour excision

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Urethral dilation procedure

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Vascular graft

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Surgical and medical procedures

Vitrectomy

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Accelerated hypertension

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Aortic aneurysm

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Aortic aneurysm rupture

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Aortic dissection

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Aortic intramural haematoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Aortic stenosis

0.29%

9/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Arterial insufficiency

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Arterial occlusive disease

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Arterial perforation

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Arterial stenosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Arteriosclerosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Arteritis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Blood pressure inadequately controlled

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Deep vein thrombosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Embolism arterial

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Embolism venous

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Extremity necrosis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Haematoma

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Hypertension

0.33%

10/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Hypertensive crisis

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.20%

6/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Hypertensive emergency

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Hypotension

0.23%

7/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Hypovolaemic shock

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Intermittent claudication

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.10%

3/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Internal haemorrhage

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Ischaemia

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Lymphocele

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Malignant hypertension

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Orthostatic hypotension

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.16%

5/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Peripheral arterial occlusive disease

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Peripheral artery aneurysm

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Peripheral artery occlusion

0.10%

3/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.07%

2/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Peripheral artery stenosis

0.13%

4/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Peripheral embolism

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Peripheral ischaemia

0.16%

5/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.13%

4/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Peripheral vascular disorder

0.07%

2/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.23%

7/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Phlebitis

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Shock

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Shock haemorrhagic

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Thromboangiitis obliterans

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Thrombophlebitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Thrombophlebitis superficial

0.00%

0/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.03%

1/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Thrombosis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Varicose vein

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Vasculitis

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Vascular disorders

Venous thrombosis limb

0.03%

1/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

0.00%

0/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months).

Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Measure	Placebo n=3076 participants at risk Participants received dalcetrapib placebo tablets matching dalcetrapib orally once daily. Placebo: dalcetrapib matching placebo tablets	Dalcetrapib n=3071 participants at risk Participants received dalcetrapib 600 mg (two 300 mg tablets) orally once daily. dalcetrapib: Cholesterol Ester Transfer Protein inhibitor, 300 mg tablets
Vascular disorders Hypertension	8.6% 266/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months). Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.	9.0% 277/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months). Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.
General disorders Chest pain	7.8% 239/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months). Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.	8.7% 268/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months). Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.
Gastrointestinal disorders Diarrhoea	6.0% 186/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months). Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.	9.8% 300/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months). Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 155/3076 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months). Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.	4.9% 152/3071 • From randomization through 14 days after end of study (median duration of follow-up was 39.9 months). Positively adjudicated endpoints by the Clinical Endpoints Committee (CEC) as well as those negatively adjudicated by the CEC and reported as unrelated to study drug by the Investigators were exempted from SAE reporting. At each study visit after randomization the Investigator asked the patient if any untoward medical event occurred since the last visit. The date of onset and end, intensity, relationship to study medication, outcome, and treatments administered for the event(s) were recorded.

Trial Outcomes & Findings for Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS (NCT NCT02525939)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

Adverse Events

Placebo

Dalcetrapib

Serious adverse events

Other adverse events

Additional Information

Dr. Don Black, Chief Medical Officer

Results disclosure agreements