Trial Outcomes & Findings for Niacin Plus Statin to Prevent Vascular Events (NCT NCT00120289)

NCT ID: NCT00120289

Last Updated: 2016-04-06

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 3414 participants
• Primary outcome timeframe: Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.
• Results posted on: 2016-04-06

Participant Flow

Participant milestones

Measure	ERN + Simvastatin Extended release niacin plus simvastatin Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Placebo + Simvastatin Simvastatin alone Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Overall Study STARTED	1718	1696
Overall Study COMPLETED	1597	1587
Overall Study NOT COMPLETED	121	109

Reasons for withdrawal

Measure	ERN + Simvastatin Extended release niacin plus simvastatin Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Placebo + Simvastatin Simvastatin alone Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Overall Study Death	96	82
Overall Study Lost to Follow-up	11	14
Overall Study Withdrawal by Subject	14	13

Baseline Characteristics

Niacin Plus Statin to Prevent Vascular Events

Baseline characteristics by cohort

Measure	ERN + Simvastatin n=1718 Participants Extended release niacin plus simvastatin Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Placebo + Simvastatin n=1696 Participants Simvastatin alone Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Total n=3414 Participants Total of all reporting groups
Lipids and Lipoproteins at Baseline Triglycerides	183.5 mg/dL STANDARD_DEVIATION 66.7 • n=5 Participants	181.9 mg/dL STANDARD_DEVIATION 66.9 • n=7 Participants	182.7 mg/dL STANDARD_DEVIATION 66.8 • n=5 Participants
Lipids and Lipoproteins at Baseline non-HDL cholesterol	110.8 mg/dL STANDARD_DEVIATION 27.5 • n=5 Participants	110.3 mg/dL STANDARD_DEVIATION 26 • n=7 Participants	110.6 mg/dL STANDARD_DEVIATION 26.8 • n=5 Participants
Lipids and Lipoproteins at Baseline HDL2-C	6 mg/dL STANDARD_DEVIATION 2.3 • n=5 Participants	6.2 mg/dL STANDARD_DEVIATION 2.4 • n=7 Participants	6.1 mg/dL STANDARD_DEVIATION 2.3 • n=5 Participants
Lipids and Lipoproteins at Baseline HDL3-C	28.5 mg/dL STANDARD_DEVIATION 4.2 • n=5 Participants	28.7 mg/dL STANDARD_DEVIATION 4.1 • n=7 Participants	28.6 mg/dL STANDARD_DEVIATION 4.1 • n=5 Participants
Lipids and Lipoproteins at Baseline Apolipoprotein A-I	122.4 mg/dL STANDARD_DEVIATION 16.2 • n=5 Participants	123.7 mg/dL STANDARD_DEVIATION 16.3 • n=7 Participants	123.1 mg/dL STANDARD_DEVIATION 16.2 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	917 Participants n=5 Participants	915 Participants n=7 Participants	1832 Participants n=5 Participants
Age, Categorical >=65 years	801 Participants n=5 Participants	781 Participants n=7 Participants	1582 Participants n=5 Participants
Age, Continuous	63.7 years STANDARD_DEVIATION 8.8 • n=5 Participants	63.7 years STANDARD_DEVIATION 8.7 • n=7 Participants	63.7 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	253 Participants n=5 Participants	251 Participants n=7 Participants	504 Participants n=5 Participants
Sex: Female, Male Male	1465 Participants n=5 Participants	1445 Participants n=7 Participants	2910 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	63 Participants n=5 Participants	77 Participants n=7 Participants	140 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1654 Participants n=5 Participants	1619 Participants n=7 Participants	3273 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Lipids and Lipoproteins at Baseline Apolipoprotein B	83.2 mg/dL STANDARD_DEVIATION 20.2 • n=5 Participants	82.9 mg/dL STANDARD_DEVIATION 20.7 • n=7 Participants	83 mg/dL STANDARD_DEVIATION 20.4 • n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Lipids and Lipoproteins at Baseline Lipoprotein (a)	77.3 mg/dL STANDARD_DEVIATION 87.8 • n=5 Participants	75.5 mg/dL STANDARD_DEVIATION 89.6 • n=7 Participants	76.4 mg/dL STANDARD_DEVIATION 88.7 • n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Black or African American	68 Participants n=5 Participants	49 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) White	1572 Participants n=5 Participants	1576 Participants n=7 Participants	3148 Participants n=5 Participants
Race (NIH/OMB) More than one race	40 Participants n=5 Participants	33 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1179 participants n=5 Participants	1167 participants n=7 Participants	2346 participants n=5 Participants
Region of Enrollment Canada	539 participants n=5 Participants	529 participants n=7 Participants	1068 participants n=5 Participants
Lipids and Lipoproteins at Baseline LDL-C	74.2 mg/dL STANDARD_DEVIATION 23.4 • n=5 Participants	74.0 mg/dL STANDARD_DEVIATION 22.7 • n=7 Participants	74.1 mg/dL STANDARD_DEVIATION 23 • n=5 Participants
Lipids and Lipoproteins at Baseline HDL-C	34.5 mg/dL STANDARD_DEVIATION 5.6 • n=5 Participants	34.9 mg/dL STANDARD_DEVIATION 5.6 • n=7 Participants	34.7 mg/dL STANDARD_DEVIATION 5.6 • n=5 Participants
Clinical History History of myocardial infarction (MI)	968 participants n=5 Participants	955 participants n=7 Participants	1923 participants n=5 Participants
Clinical History History of CABG	600 participants n=5 Participants	627 participants n=7 Participants	1227 participants n=5 Participants
Clinical History History of Percutaneous Coronary Intervention	1057 participants n=5 Participants	1044 participants n=7 Participants	2101 participants n=5 Participants
Clinical History History of stroke or cerebrovascular disease	358 participants n=5 Participants	362 participants n=7 Participants	720 participants n=5 Participants
Clinical History History of peripheral vascular disease	234 participants n=5 Participants	231 participants n=7 Participants	465 participants n=5 Participants
Clinical History Metabolic syndrome	1414 participants n=5 Participants	1353 participants n=7 Participants	2767 participants n=5 Participants
Clinical History History of diabetes (Type 1 or 2)	588 participants n=5 Participants	570 participants n=7 Participants	1158 participants n=5 Participants
Concomitant Medications at Baseline Statins	1595 participants n=5 Participants	1601 participants n=7 Participants	3196 participants n=5 Participants
Concomitant Medications at Baseline Beta-blockers	1377 participants n=5 Participants	1342 participants n=7 Participants	2719 participants n=5 Participants
Concomitant Medications at Baseline ACE inhibitor or Angiotensin Receptor Blocker	1258 participants n=5 Participants	1271 participants n=7 Participants	2529 participants n=5 Participants
Concomitant Medications at Baseline Aspirin or other antiplatelet or anticoagulant	1680 participants n=5 Participants	1654 participants n=7 Participants	3334 participants n=5 Participants

PRIMARY outcome

Timeframe: Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.

Population: Intention-to-treat

Outcome measures

Measure	ERN + Simvastatin n=1718 Participants Extended release niacin plus simvastatin Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Placebo + Simvastatin n=1696 Participants Simvastatin alone Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization	282 participants	274 participants

SECONDARY outcome

Timeframe: Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months

Outcome measures

Measure	ERN + Simvastatin n=1718 Participants Extended release niacin plus simvastatin Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Placebo + Simvastatin n=1696 Participants Simvastatin alone Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke	171 participants	158 participants

SECONDARY outcome

Timeframe: Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months

Population: Intention to treat

Outcome measures

Measure	ERN + Simvastatin n=1718 Participants Extended release niacin plus simvastatin Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Placebo + Simvastatin n=1696 Participants Simvastatin alone Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke	156 participants	138 participants

SECONDARY outcome

Timeframe: Time to first event measured from date of randomization through last follow-up visit (common termination), for an average of 36 months follow-up, maximum 66 months.

Population: Intention to treat

Outcome measures

Measure	ERN + Simvastatin n=1718 Participants Extended release niacin plus simvastatin Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Placebo + Simvastatin n=1696 Participants Simvastatin alone Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Cardiovascular Mortality	45 participants	38 participants

Adverse Events

ERN + Simvastatin

Serious events: 587 serious events

Other events: 1413 other events

Deaths: 0 deaths

Placebo + Simvastatin

Serious events: 551 serious events

Other events: 1345 other events

Deaths: 0 deaths

Serious adverse events

Measure	ERN + Simvastatin n=1718 participants at risk Extended release niacin plus simvastatin Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Placebo + Simvastatin n=1696 participants at risk Simvastatin alone Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Blood and lymphatic system disorders Anaemia	0.99% 17/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.59% 10/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Blood and lymphatic system disorders Chronic lymphocytic leukaemia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Blood and lymphatic system disorders Iron deficiency anaemia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Blood and lymphatic system disorders Leukopenia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Blood and lymphatic system disorders Pancytopenia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Blood and lymphatic system disorders Thrombocytopenia	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Acute myocardial infarction	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Acute pulmonary oedema	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Angina pectoris	0.93% 16/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.2% 21/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Angina unstable	0.35% 6/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Aortic valve calcification	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Aortic valve disease	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Arrhythmia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Arteriospasm coronary	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Atrial fibrillation	1.6% 27/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.5% 25/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Atrial flutter	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Atrial tachycardia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Atrial thrombosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Atrioventricular block	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Atrioventricular block third degree	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Bradycardia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.47% 8/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Bundle branch block right	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Cardiac aneurysm	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Cardiac arrest	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Cardiac failure	0.58% 10/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.53% 9/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Cardiac failure chronic	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Cardiac failure congestive	1.2% 21/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.8% 30/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Cardiomyopathy	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Chest discomfort	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.41% 7/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Chest pain	2.5% 43/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.4% 57/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Cor pulmonale	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Coronary artery disease	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Cyanosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Diastolic dysfunction	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Dyspnoea	1.8% 31/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.2% 38/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Dyspnoea exertional	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Dyspnoea paroxysmal nocturnal	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Extrasystoles	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Intracardiac thrombus	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Ischaemic cardiomyopathy	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Left ventricular failure	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Mitral valve incompetence	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Myocardial infarction	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Myocardial ischaemia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Nodal rhythm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Palpitations	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.41% 7/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Presyncope	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Pulmonary oedema	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Restrictive cardiomyopathy	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Sick sinus syndrome	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Sinus bradycardia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Subvalvular aortic stenosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Supraventricular extrasystoles	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Supraventricular tachycardia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Syncope	1.2% 21/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.1% 19/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Tachycardia	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Tachycardia paroxysmal	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Tricuspid valve incompetence	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Ventricle rupture	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Ventricular dysfunction	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Ventricular extrasystoles	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Ventricular tachycardia	0.35% 6/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Congenital, familial and genetic disorders Hypospadias	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Congenital, familial and genetic disorders Sickle cell anaemia with crisis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Ear and labyrinth disorders Vertigo	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Ear and labyrinth disorders Vestibular neuronitis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Endocrine disorders Adrenal insufficiency	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Endocrine disorders Hypercalcaemia of malignancy	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Endocrine disorders Hyperthyroidism	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Endocrine disorders Hypothyroidism	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Eye disorders Chorioretinal atrophy	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Eye disorders Diplopia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Eye disorders Eye inflammation	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Eye disorders Optic ischaemic neuropathy	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Eye disorders Retinal detachment	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Eye disorders Vision blurred	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Abdominal adhesions	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Abdominal discomfort	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Abdominal distension	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Abdominal hernia	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Abdominal pain	1.3% 22/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.59% 10/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Abdominal pain lower	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Abdominal pain upper	0.47% 8/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Abdominal strangulated hernia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Anal fistula	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Aphthous stomatitis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Appendicitis perforated	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Colitis	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Colitis ischaemic	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Colonic fistula	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Colonic polyp	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Constipation	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Crohn's disease	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Diarrhoea	0.52% 9/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Diarrhoea haemorrhagic	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Diverticulitis oesophageal	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Diverticulum	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Dyspepsia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Dysphagia	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Enteritis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Epigastric discomfort	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Faecaloma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Faeces discoloured	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Gastric haemorrhage	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Gastric ulcer	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Gastritis	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Gastroduodenitis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Gastroenteritis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.41% 7/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.77% 13/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Gastrointestinal motility disorder	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Haematochezia	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Haemorrhoids	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Hiatus hernia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Ileus	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Inguinal hernia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Inguinal hernia, obstructive	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Intestinal ischaemia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Intestinal obstruction	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Large intestine perforation	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Melaena	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Nausea	0.70% 12/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.41% 7/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Odynophagia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Oesophageal stenosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Oesophagitis	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Pancreatic mass	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Pancreatitis	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Pancreatitis acute	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Peptic ulcer	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Pharyngoesophageal diverticulum	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Rectal haemorrhage	0.64% 11/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Rectal polyp	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Small intestinal obstruction	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Umbilical hernia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Volvulus	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Vomiting	1.2% 20/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.53% 9/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Abasia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Adverse drug reaction	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Asthenia	0.58% 10/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.47% 8/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Chest discomfort	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Chest pain	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Chills	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Cyst	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Death	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Face oedema	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Facial pain	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Fatigue	0.64% 11/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Feeling abnormal	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Gait disturbance	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders General physical health deterioration	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Hernia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Hyperthermia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Hypothermia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Impaired healing	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Influenza like illness	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Malaise	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Mass	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Multi-organ failure	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Non-cardiac chest pain	0.70% 12/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.1% 18/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Oedema	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Oedema peripheral	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Pain	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Pyrexia	0.35% 6/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.47% 8/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Sudden death	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Thirst	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Bile duct stone	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Biliary colic	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Cholangitis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Cholecystitis	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Cholecystitis acute	0.35% 6/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Cholelithiasis	0.47% 8/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.41% 7/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Gallbladder pain	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Hepatic cirrhosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Hepatic congestion	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Hepatic lesion	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Hyperbilirubinaemia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Jaundice	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Jaundice cholestatic	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Hepatobiliary disorders Portal vein thrombosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Immune system disorders Anaphylactic shock	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Abdominal abscess	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Abscess intestinal	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Abscess limb	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Abscess neck	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Appendicitis	0.47% 8/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Arthritis bacterial	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Bacteraemia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Bacterial infection	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Bacterial sepsis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Biliary sepsis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Bronchitis	0.41% 7/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Bronchitis acute	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Cellulitis	1.5% 26/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.77% 13/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Clostridium difficile colitis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Device related infection	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Diverticulitis	0.35% 6/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Endocarditis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Enterocolitis infectious	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Gangrene	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Gastroenteritis	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Gastroenteritis cryptosporidial	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Gastroenteritis viral	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Hepatitis B	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Herpes zoster	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Incision site infection	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Infected insect bite	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Infection	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Influenza	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Intervertebral discitis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Labyrinthitis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Liver abscess	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Lobar pneumonia	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Localised infection	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Lung infection	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Meningitis aseptic	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Necrotising fasciitis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Oesophageal candidiasis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Osteomyelitis	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Perianal abscess	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Pneumonia	2.2% 38/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.6% 27/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Pneumonia bacterial	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Pneumonia klebsiella	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Pneumonia primary atypical	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Pneumonia viral	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Postoperative infection	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Postoperative wound infection	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Pyelonephritis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Rectal abscess	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Respiratory tract infection	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Sepsis	0.47% 8/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.59% 10/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Septic embolus	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Septic shock	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Sinusitis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Staphylococcal bacteraemia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Staphylococcal infection	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Staphylococcal sepsis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Sweat gland infection	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Tracheobronchitis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Upper respiratory tract infection	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Urinary tract infection	1.1% 19/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.59% 10/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Urosepsis	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Wound infection	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Anastomotic leak	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Anastomotic stenosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Ankle fracture	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Cervical vertebral fracture	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Excoriation	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Fall	0.35% 6/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.53% 9/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Femur fracture	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Foreign body trauma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Fracture of penis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Hand fracture	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Head injury	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Hip fracture	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Humerus fracture	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Incision site complication	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Incision site haemorrhage	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Incisional hernia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Injury	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Injury asphyxiation	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Joint injury	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Joint sprain	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Lower limb fracture	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Multiple drug overdose	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Multiple fractures	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Narcotic intoxication	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Pharyngeal injury	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Polytraumatism	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Post laminectomy syndrome	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Post procedural complication	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Post procedural haematuria	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Post procedural haemorrhage	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Post procedural urine leak	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Postoperative fever	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Postoperative renal failure	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Postoperative wound complication	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Procedural hypotension	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Radius fracture	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Renal injury	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Rib fracture	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Road traffic accident	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Skeletal injury	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Skin laceration	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Spinal compression fracture	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Spinal fracture	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Splenic injury	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Stent-graft endoleak	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Subdural haematoma	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Tendon injury	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Traumatic brain injury	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Wound decomposition	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Arteriogram coronary	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Arteriogram coronary normal	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Aspartate aminotransferase increased	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Blood creatine phosphokinase increased	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Blood creatinine increased	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Blood glucose decreased	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Blood glucose increased	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Blood potassium increased	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Blood pressure increased	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Cardiac stress test abnormal	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Ejection fraction abnormal	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Ejection fraction decreased	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Haematocrit decreased	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Haemoglobin decreased	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Heart rate decreased	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Heart rate increased	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Hepatic enzyme increased	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations International normalised ratio increased	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Intraocular pressure increased	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Oxygen consumption increased	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Prostatic specific antigen increased	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Transaminases increased	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Weight decreased	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Weight increased	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Decreased appetite	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Dehydration	0.87% 15/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Diabetes mellitus	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Diabetes mellitus non-insulin-dependent	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Diabetic foot	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Diabetic ketoacidosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Diabetic ulcer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Electrolyte imbalance	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Failure to thrive	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Fluid overload	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Fluid retention	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Gout	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Hyperglycaemia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Hyperkalaemia	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Hypoglycaemia	0.35% 6/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Hypokalaemia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Hypovolaemia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Malnutrition	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Metabolic acidosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Oral intake reduced	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Arthralgia	0.76% 13/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.1% 18/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Back pain	0.41% 7/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.41% 7/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Bunion	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Bursitis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Joint effusion	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Joint swelling	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Muscle spasms	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Muscular weakness	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Myalgia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Neck pain	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Osteoarthritis	1.4% 24/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.7% 28/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Osteonecrosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Pain in extremity	0.64% 11/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.41% 7/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Sensation of heaviness	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Spondylitis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Tendonitis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of ureter	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage IV	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone neoplasm malignant	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the caecum	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the gastrointestinal tract	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer recurrent	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.47% 8/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.83% 14/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant lymphoid neoplasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant urinary tract neoplasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage I	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IIIA	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.47% 8/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.59% 10/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage II	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma stage unspecified	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal cord neoplasm	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsillar neoplasm	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Amnesia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Aphasia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Balance disorder	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Cerebral haemorrhage	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Cerebrovascular accident	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Cervicobrachial syndrome	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Convulsion	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Coordination abnormal	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Dementia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Dementia Alzheimer's type	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Depressed level of consciousness	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Dizziness	1.2% 21/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.1% 19/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Drooling	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Dysarthria	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Essential tremor	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Facial palsy	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Haemorrhage intracranial	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Headache	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Hemiparesis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Hypertensive encephalopathy	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Hypoaesthesia	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Intracranial aneurysm	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Lethargy	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Loss of consciousness	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Lumbar radiculopathy	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Migraine	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Migraine with aura	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Myelitis transverse	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Myoclonus	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Nerve compression	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Neuritis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Normal pressure hydrocephalus	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Paraesthesia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Paresis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Parkinson's disease	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Partial seizures	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Post herpetic neuralgia	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Presyncope	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Radicular pain	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Sciatica	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Simple partial seizures	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Somnolence	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Spinal claudication	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Subarachnoid haemorrhage	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Syncope vasovagal	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Transient ischaemic attack	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Tremor	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Affective disorder	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Anger	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Anxiety	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Bipolar I disorder	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Confusional state	0.41% 7/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.47% 8/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Delirium	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Depression	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Depression suicidal	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Depressive symptom	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Disorientation	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Dysphasia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Hallucination	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Impaired self-care	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Insomnia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Major depression	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Mental disorder	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Mental status changes	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Panic attack	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Post-traumatic stress disorder	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Psychotic disorder	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Stress	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Psychiatric disorders Suicidal ideation	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Acute prerenal failure	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Calculus ureteric	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Calculus urinary	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Dysuria	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Glomerulonephritis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Haematuria	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Hydronephrosis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Nephrolithiasis	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.41% 7/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Neurogenic bladder	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Obstructive uropathy	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Pollakiuria	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Pyuria	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Renal colic	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Renal cyst	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Renal disorder	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Renal failure	0.41% 7/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Renal failure acute	1.0% 18/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.88% 15/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Renal failure chronic	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Stress urinary incontinence	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Ureteric obstruction	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Ureteric stenosis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Urethral obstruction	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Urethral perforation	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Renal and urinary disorders Urinary retention	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Reproductive system and breast disorders Benign prostatic hyperplasia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Reproductive system and breast disorders Breast cancer in situ	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Reproductive system and breast disorders Endometrial cancer recurrent	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Reproductive system and breast disorders Pelvic haematoma	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Reproductive system and breast disorders Pelvic pain	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Reproductive system and breast disorders Penile pain	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Reproductive system and breast disorders Postmenopausal haemorrhage	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Reproductive system and breast disorders Prostatitis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Reproductive system and breast disorders Vaginal haemorrhage	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Asthma	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.87% 15/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.65% 11/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Cough	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Cryptogenic organising pneumonia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Influenza	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Productive cough	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.41% 7/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Throat tightness	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Angioneurotic oedema	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Decubitus ulcer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Erythema	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Hyperhidrosis	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Hypoaesthesia facial	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Pruritus generalised	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Rash	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Rash pruritic	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Skin ulcer	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Swelling face	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Surgical and medical procedures Cardioversion	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Surgical and medical procedures Coronary revascularisation	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Surgical and medical procedures Hypotensive anaesthesia procedure	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Surgical and medical procedures Peripheral revascularisation	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Surgical and medical procedures Shoulder arthroplasty	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Surgical and medical procedures Spinal decompression	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Surgical and medical procedures Stent placement	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Surgical and medical procedures Therapeutic embolisation	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Surgical and medical procedures Toe amputation	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Aneurysm	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Aortic aneurysm	0.47% 8/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.65% 11/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Aortic aneurysm rupture	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Aortic stenosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Aorto-duodenal fistula	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Arteriovenous fistula	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Carotid artery aneurysm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Carotid artery disease	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Carotid artery stenosis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Circulatory collapse	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Deep vein thrombosis	0.52% 9/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.35% 6/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Femoral arterial stenosis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Flushing	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Haematoma	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Hypertension	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Hypertensive crisis	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Hypertensive emergency	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Hypotension	0.64% 11/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.47% 8/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Iliac artery stenosis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Intermittent claudication	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.24% 4/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Orthostatic hypotension	0.12% 2/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Peripheral artery aneurysm	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Peripheral ischaemia	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Peripheral vascular disorder	0.17% 3/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.18% 3/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Pulmonary embolism	0.23% 4/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.29% 5/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Pulmonary hypertension	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Shock haemorrhagic	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Thrombosis	0.00% 0/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.12% 2/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Vascular pseudoaneurysm	0.29% 5/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.06% 1/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Vasospasm	0.06% 1/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	0.00% 0/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)

Other adverse events

Measure	ERN + Simvastatin n=1718 participants at risk Extended release niacin plus simvastatin Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target	Placebo + Simvastatin n=1696 participants at risk Simvastatin alone Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target
Blood and lymphatic system disorders Anaemia	2.4% 41/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.0% 34/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Angina pectoris	2.5% 43/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.7% 46/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Atrial fibrillation	2.5% 43/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.8% 30/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Chest pain	6.5% 112/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	5.6% 95/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Dyspnoea	5.2% 89/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	5.2% 89/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Cardiac disorders Dyspnoea exertional	1.5% 26/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.4% 40/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Eye disorders Cataract	4.7% 80/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	4.5% 77/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Abdominal pain	2.3% 39/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.0% 34/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Diarrhoea	7.9% 136/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.7% 63/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Nausea	3.2% 55/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.4% 40/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Gastrointestinal disorders Vomiting	2.7% 46/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.7% 28/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Fatigue	5.1% 87/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	4.4% 74/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Non-cardiac chest pain	1.6% 27/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.5% 42/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
General disorders Oedema peripheral	3.8% 66/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	4.3% 73/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Bronchitis	4.8% 82/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	4.0% 68/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Cellulitis	2.1% 36/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.8% 30/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Herpes zoster	3.1% 53/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.7% 29/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Influenza	3.6% 61/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.7% 62/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Nasopharyngitis	6.6% 113/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	7.1% 121/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Pneumonia	2.2% 38/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.1% 52/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Sinusitis	4.7% 80/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	4.2% 71/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Upper respiratory tract infection	4.2% 72/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.5% 59/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Infections and infestations Urinary tract infection	3.5% 60/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.1% 53/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Injury, poisoning and procedural complications Contusion	1.7% 29/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.1% 36/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Investigations Blood glucose increased	6.5% 112/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	4.6% 78/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Diabetes mellitus	3.9% 67/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.4% 41/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Metabolism and nutrition disorders Gout	3.8% 66/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.8% 65/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 138/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	9.3% 158/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Back pain	7.0% 120/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	7.2% 122/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Muscle spasms	2.7% 46/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.0% 51/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.4% 75/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	5.2% 88/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Myalgia	3.1% 53/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.1% 53/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Neck pain	2.2% 38/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.1% 35/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Osteoarthritis	2.7% 47/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.9% 50/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Musculoskeletal and connective tissue disorders Pain in extremity	7.8% 134/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	8.7% 147/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Dizziness	5.5% 95/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	7.2% 122/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Headache	3.6% 61/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.0% 51/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Nervous system disorders Hypoaesthesia	2.1% 36/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.1% 35/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Respiratory, thoracic and mediastinal disorders Cough	3.3% 57/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.1% 52/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Pruritus	2.7% 47/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	1.6% 27/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Skin and subcutaneous tissue disorders Rash	3.4% 58/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	2.2% 38/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)
Vascular disorders Hypertension	3.4% 59/1718 • Randomization through final study visit after recommendation to curtail study (June - September 2011)	3.4% 58/1696 • Randomization through final study visit after recommendation to curtail study (June - September 2011)

Additional Information

Ruth McBride

Axio Research, LLC

Phone: 206-577-0212

Email: ruthm@axioresearch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place